Compact On-Body Physiological Monitoring Devices and Methods Thereof

ABSTRACT

Methods and devices to monitor an analyte in body fluid are provided. Embodiments include continuous or discrete acquisition of analyte related data from a transcutaneously positioned analyte sensor automatically or on demand upon request from a user.

RELATED APPLICATIONS

The present application claims priority under 35 U.S.C. §119(e) to U.S.provisional application No. 61/149,639 filed Feb. 3, 2009 entitled“Compact On-Body Physiological Monitoring Devices and Methods Thereof”,the disclosure of which is incorporated by reference for all purposes.The present application is further related to US patent Applicationentitled “Analyte Sensor and Apparatus for Insertion of the Sensor(Attorney Docket No. 031312-06099) filed concurrently on Feb. 1, 2010,and the disclosure of which is incorporated by reference for allpurposes.

BACKGROUND

The detection of the level of glucose or other analytes, such aslactate, oxygen or the like, in certain individuals is vitally importantto their health. For example, the monitoring of glucose is particularlyimportant to individuals with diabetes. Diabetics may need to monitorglucose levels to determine when insulin is needed to reduce glucoselevels in their bodies or when additional glucose is needed to raise thelevel of glucose in their bodies.

Devices have been developed for continuous or automatic monitoring ofanalytes, such as glucose, in bodily fluid such as in the blood streamor in interstitial fluid. Some of these analyte measuring devices areconfigured so that at least a portion of the devices are positionedbelow a skin surface of a user, e.g., in a blood vessel or in thesubcutaneous tissue of a user.

Ease of insertion and use, including minimal user intervention andon-body size and height (or thickness) of such transcutaneous orpercutaneous medical devices that are worn on the body are important inusability, wearability, and comfort during the device usage. Moreover,for many of such medical devices that require a battery or a similarpower source to perform the device specific operations, power managementas well as shelf life is important.

SUMMARY

Embodiments of the subject disclosure include devices and methods andkits for providing sensor electronics assembly including an analytesensor for monitoring of analyte levels such as glucose levels over asensing time period. Sensing time period may be determined by theanalyte sensor life, for example, including, but not limited to aboutthree days or more, about five days or more, or about seven days ormore, or about fourteen days or more.

Embodiments include methods, devices and systems for monitoring glucoselevels and obtaining glucose measurements that are discreet, automated,minimally invasive and with reduced pain and repetition of glucosetesting procedures to obtain multiple discrete measurements over thesensing time period. Also provided are kits.

Embodiments further include a control unit, a control command generatorcoupled to the control unit to receive a control signal and to generatea control command based on a carrier signal, an antenna section coupledto the control command generator to transmit the control command withthe carrier signal and to receive a backscatter response data packetusing the carrier signal, and a receiver section coupled to the antennasection to process the received backscatter response data packet and togenerate an output glucose data.

Embodiments also include real time discrete glucose measurement dataacquisition on-demand, as desired by the user or upon request, based on,for example, RFID data communication techniques for data transmissionand acquisition from the analyte sensor/electronics assembly or theon-body patch device including the analyte sensor and the dataprocessing and communication components provided in a compact, lowprofile housing and placed on the skin surface of the user. The analytesensor in certain embodiments includes a portion that istranscutaneously positioned and maintained in fluid contact with aninterstitial fluid under the skin surface continuously during thesensing time period as discussed above, for example.

These and other features, objects and advantages of the presentdisclosure will become apparent to those persons skilled in the art uponreading the details of the present disclosure as more fully describedbelow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a data monitoring and management system such as, forexample, an analyte (e.g., glucose) monitoring system in accordance withcertain embodiments of the present disclosure;

FIG. 2 illustrates a data monitoring and management system for real timeglucose measurement data acquisition and processing in one aspect of thepresent disclosure;

FIG. 3 is a block diagram of a receiver/monitor unit such as that shownin FIG. 1 in accordance with certain embodiments;

FIG. 4 is a block diagram of a reader device/receiver unit such as thatshown in FIG. 2 in one aspect of the present disclosure;

FIG. 5 is an exemplary schematic of an on-body patch device including anintegrated sensor and sensor electronics assembly for use in themonitoring systems of FIGS. 1 and 2 in one aspect of the presentdisclosure;

FIG. 6 is a block diagram of the integrated sensor and sensorelectronics assembly for use in the monitoring systems of FIGS. 1 and 2in another aspect of the present disclosure;

FIG. 7 is a schematic of the reader device/receiver unit for use in themonitoring systems of FIGS. 1 and 2 in accordance with one aspect of thepresent disclosure;

FIGS. 8A and 8B illustrate a top view and a side view, respectively, ofantenna and electronic circuit layout of the on-body patch deviceincluding an sensor and sensor electronics assembly for use in themonitoring systems of FIGS. 1 and 2 in one aspect of the presentdisclosure;

FIG. 9 illustrates an exemplary circuit schematic of the on-body patchdevice including an sensor and sensor electronics assembly in accordancewith aspects of the present disclosure;

FIG. 10A is a perspective view of the components of the on-body patchdevice including sensor and sensor electronics assembly in accordancewith one aspect of the present disclosure;

FIG. 10B is another perspective view of the components of the on-bodypatch device including sensor and sensor electronics assembly inaccordance with one aspect of the present disclosure;

FIG. 10C is another perspective view of the assembled on-body patchdevice including sensor and sensor electronics assembly in accordancewith one aspect of the present disclosure;

FIGS. 11A-11C illustrate circuit layouts for the sensor electronicsassembly in the on-body patch device including sensor and sensorelectronics assembly in accordance with embodiments of the presentdisclosure;

FIGS. 12A-12B illustrate pre-deployment and post insertionconfigurations of the insertion device for positioning the on-body patchdevice including sensor and sensor electronics assembly in accordancewith embodiments of the present disclosure;

FIGS. 12C-12G illustrate cross sectional perspective views of theoperation of the insertion device for deploying the on-body patch deviceincluding sensor and sensor electronics assembly in accordance withembodiments of the present disclosure;

FIGS. 13A-13B illustrate embodiments of a power supply switch mechanismincluding conductive plugs of the on-body patch device including sensorand sensor electronics assembly in accordance with embodiments of thepresent disclosure;

FIGS. 13C-13E illustrate another configuration of the power supplyswitch mechanism including conductive pads of the on-body patch deviceincluding sensor and sensor electronics assembly in accordance withembodiments of the present disclosure;

FIG. 14 illustrates a power supply switch mechanism including aninternal switch with a push rod activation of the on-body patch deviceincluding sensor and sensor electronics assembly in accordance withembodiments of the present disclosure;

FIG. 15 illustrates a power supply switch mechanism including introducerretraction trigger activation of the on-body patch device includingsensor and sensor electronics assembly in accordance with embodiments ofthe present disclosure;

FIG. 16 illustrates a power supply switch mechanism with a contactswitch of the on-body patch device including sensor and sensorelectronics assembly in accordance with embodiments of the presentdisclosure;

FIGS. 17A-17B illustrate a power supply switch mechanism with a batterycontact locking mechanism of the on-body patch device including sensorand sensor electronics assembly in accordance with embodiments of thepresent disclosure; and

FIGS. 18A-18B illustrate a power supply switch mechanism with a bi-modaldome switch of the on-body patch device including sensor and sensorelectronics assembly in accordance with embodiments of the presentdisclosure.

INCORPORATION BY REFERENCE

The following patents, applications and/or publications are incorporatedherein by reference for all purposes: U.S. Pat. Nos. 4,545,382;4,711,245; 5,262,035; 5,262,305; 5,264,104; 5,320,715; 5,509,410;5,543,326; 5,593,852; 5,601,435; 5,628,890; 5,820,551; 5,822,715;5,899,855; 5,918,603; 6,071,391; 6,103,033; 6,120,676; 6,121,009;6,134,461; 6,143,164; 6,144,837; 6,161,095; 6,175,752; 6,270,455;6,284,478; 6,299,757; 6,338,790; 6,377,894; 6,461,496; 6,503,381;6,514,460; 6,514,718; 6,540,891; 6,560,471; 6,579,690; 6,591,125;6,592,745; 6,600,997; 6,605,200; 6,605,201; 6,616,819; 6,618,934;6,650,471; 6,654,625; 6,676,816; 6,730,200; 6,736,957; 6,746,582;6,749,740; 6,764,581; 6,773,671; 6,881,551; 6,893,545; 6,932,892;6,932,894; 6,942,518; 7,167,818; and 7,299,082; U.S. PublishedApplication Nos. 2004/0186365; 2005/0182306; 2007/0056858; 2007/0068807;2007/0227911; 2007/0233013; 2008/0081977; 2008/0161666; and2009/0054748; U.S. patent application Ser. Nos. 12/131,012; 12/242,823;and 12/363,712; and U.S. Provisional Application Ser. Nos. 61/149,639;61/155,889; 61/155,891; 61/155,893; 61/165,499; 61/230,686; 61/227,967and 61/238,461.

DETAILED DESCRIPTION

Within the scope of the present disclosure, there are provided devices,systems, kits and methods for providing compact, low profile, on-bodyphysiological parameter monitoring device (physiological parameters suchas for example, but not limited to analyte levels, temperature levels,heart rate, etc), configured for single or multiple use over apredetermined time period, which provide a low profile geometry,effective power management, improved shelf life, and ease and comfort ofuse including device positioning, and activation. Embodiments include anon-body assembly including a transcutaneously positioned analyte sensorand sensor electronics in a compact, low profile integrated assembly andcoupled to an insertion device for deployment.

Embodiments include continuous glucose monitoring (CGM) system orroutines or functions for execution operations to continuously orsemi-continuously monitor an analyte level such as glucose level withthe transcutaneously positioned analyte sensor, where the real timeanalyte measurements are provided to a data receiver unit, a readerdevice, a data repeater or relay device such as data processing module,a data processing terminal or a remote terminal for data processingautomatically upon data sampling at predetermined time intervals orbased on programmed or programmable data transmission schedule. Dataprocessing may include display, storage, execution of related alarm ornotification functions, and analysis such as generating charts or graphsbased on, for example, the monitored analyte levels received from thesensor/sensor electronics assembly.

Embodiments further include analyte data acquisition in real time wherethe analyte level detected by the transcutaneously positioned analytesensor is stored either permanently or temporarily in a memory orstorage unit of a data processing unit or an integrated sensor and dataprocessing unit assembly, such as an on-body patch device (stored forexample, for about one day or less, or for about 10 hours or less, orfor about 5 hours or less, or for about 3 hours or less, or for aboutone hour or less). In such embodiments, the receiver unit or the readerdevice may be used to acquire the detected analyte level in real time,and/or on-demand or upon request using, for example, RFID communicationprotocol or other suitable data communication protocols. Sampled analyterelated data in certain embodiments are received by the receiver unit orthe reader device upon activation or initiation by the user or thepatient, for example, of a switch or other initiation mechanism toinitiate the data transfer or provide data request command. Suchactivation switch or mechanism may be provided or included in the userinterface of the reader device or the receiver unit.

Embodiments of the present disclosure relate to methods and devices fordetecting at least one analyte such as glucose in body fluid.Embodiments include glucose measurements by an on-body patch device thatincludes a transcutaneously positioned analyte sensor in fluid contactwith the body fluid such as interstitial fluid, and sensor electronicsin signal communication with the analyte sensor, where the on-body patchdevice is configured to transmit one or more signals or data packetsassociated with a monitored analyte level upon detection of a readerdevice or the receiver unit of the analyte monitoring system within apredetermined proximity for a period of time (for example, about 10seconds or less, or preferably about 5 seconds or less, or preferablyabout 2 seconds or less, or until a confirmation, such as an audiblenotification, is output on the reader device/receiver unit indicatingsuccessful acquisition of the analyte related signal from the on-bodypatch device).

For example, in one aspect, when a reader device/receiver unit ispositioned within approximately 5 inches or less (or about 10 inches orless, for example) to the on-body patch device that is adhesively placedor mounted on the skin surface of a patient (with the analyte sensortranscutaneously positioned in fluid contact under the skin surface andin signal communication with the sensor electronics of the on-body patchdevice), a radio frequency source within the reader device/receiver unitmay be configured to provide RF power to the on-body patch device. Inresponse, the on-body patch device in one embodiment may be configuredto generate an output signal (e.g., an RF signal) and transmit it to thereader device/receiver unit which includes, among others data indicatingthe glucose measurement. In one aspect the signal communication and/orRF power transmission may initiate automatically upon detection of thereader device/receiver unit within a predetermined proximity to theon-demand patch device, or alternatively the reader device/receiver unitmay require a user activation or confirmation prior to initiating signalcommunication and/or RF power transmission with the on-body patch deviceas discussed above.

In a further aspect, the transmitted data from the on-body patch deviceto the reader device/receiver unit may include glucose trend informationthat was stored in the on-body patch device for a predetermined timeperiod, since the initialization of the sensor and positioning it influid contact with the interstitial fluid, or since the lasttransmission of data to the reader device, or any one or morecombinations of the above. For example, the trend information mayindicate the variation in the monitored glucose level over theparticular time period based on signals received from the analyte sensorand stored in the on-body patch device.

As described in further detail below, the on-body patch device mayoptionally include an output component such as a speaker, a lightindicator (for example, an LED indicator), or the like to provide one ormore indications associated with its functions such as a successfultransmission of data to the reader device or the receiver unit, alarm oralert conditions associated with its internal components, or a detectionof the RF power received from the reader device or the receiver unit,for example. By way of a non-limiting example, one or more exemplaryoutput indication may include an audible sound (including for example, ashort tone, a changing tone, multi-tone, one or more programmedringtones or one or more combinations thereof), a visual indication suchas a blinking light of the LED indicator, a solid light on the LEDindicator maintained at a predetermined or programmed or programmabletime period (for example, 5 seconds), each of which may bepre-programmed in the on-body patch device, or alternativelyprogrammable by the user through the user interface of the readerdevice/receiver unit when in communication with the on-body patchdevice.

In a further aspect, when an alarm or alert condition is detected (forexample, a detected glucose level monitored by the analyte sensor thatis outside a predetermined acceptable range indicating a physiologicalcondition which requires attention or intervention for medical treatmentor analysis (for example, a hypoglycemic condition, a hyperglycemiccondition, an impending hyperglycemic condition or an impendinghypoglycemic condition)), the one or more output indications may begenerated in the on-body patch device and presented to the patient orthe user so that corrective action may be timely taken. Alternatively,the output indications may be additionally or alternatively presented oroutput on the reader device/receiver unit when, for example, the readerdevice/receiver unit is within range of the on-body patch device

In certain aspects, future or anticipated analyte levels may bepredicted based on information obtained, e.g., the current analytelevel, the rate of change of the analyte level and analyte trendinformation. Predictive alarms may be programmed or programmable in thereader device/receiver unit, or the on-body patch device, or both, andmay be configured to notify the user of a predicted analyte levels thatmay be of concern in advance of the user's analyte level reaching thefuture level. This provides the user an opportunity to take correctiveaction.

Before the present disclosure is described in additional detail, it isto be understood that this disclosure is not limited to particularembodiments described, as such may, of course, vary. It is also to beunderstood that the terminology used herein is for the purpose ofdescribing particular embodiments only, and is not intended to belimiting, since the scope of the present disclosure will be limited onlyby the appended claims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the disclosure. The upper and lowerlimits of these smaller ranges may independently be included in thesmaller ranges is also encompassed within the disclosure, subject to anyspecifically excluded limit in the stated range. Where the stated rangeincludes one or both of the limits, ranges excluding either or both ofthose included limits are also included in the disclosure.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this disclosure belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present disclosure, the preferredmethods and materials are now described. All publications mentionedherein are incorporated herein by reference to disclose and describe themethods and/or materials in connection with which the publications arecited.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present disclosure isnot entitled to antedate such publication by virtue of prior disclosure.Further, the dates of publication provided may be different from theactual publication dates which may need to be independently confirmed.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual embodiments described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentdisclosure.

The figures shown herein are not necessarily drawn to scale, with somecomponents and features being exaggerated for clarity.

Generally, embodiments of the present disclosure relate to methods anddevices for detecting at least one analyte such as glucose in bodyfluid. In certain embodiments, the present disclosure relates to thecontinuous and/or automatic in vivo monitoring of the level of ananalyte using an analyte sensor.

Accordingly, embodiments include analyte monitoring devices and systemsthat include an analyte sensor—at least a portion of which ispositionable beneath the skin of the user—for the in vivo detection, ofan analyte, such as glucose, lactate, and the like, in a body fluid.Embodiments include wholly implantable analyte sensors and analytesensors in which only a portion of the sensor is positioned under theskin and a portion of the sensor resides above the skin, e.g., forcontact to a transmitter, receiver, transceiver, processor, etc. Thesensor may be, for example, subcutaneously positionable in a patient forthe continuous or periodic monitoring of a level of an analyte in apatient's interstitial fluid.

For the purposes of this description, continuous monitoring and periodicmonitoring will be used interchangeably, unless noted otherwise.Discrete monitoring as used herein includes the acquisition or receptionof monitored analyte data where real time monitored analyte levelinformation is received or acquired on demand or in response to arequest to the on-body patch device including sensor and sensorelectronics. That is, embodiments include analyte sensors and sensorelectronics which sample and process analyte related information basedon a programmed or programmable schedule such as every minute, everyfive minutes and so on. Such analyte monitoring routines may be reportedor transmitted in real time to the receiver unit/reader device at thetime of data sampling and processing. Alternatively, as discussed, thecontinuously sampled analyte data and processed analyte related signalsmay be stored and transmitted to a remote location such as the receiverunit, data processing module, the data processing terminal, the readerdevice or the remote terminal in response to a request for suchinformation from the remote location. The analyte level may becorrelated and/or converted to analyte levels in blood or other fluids.In certain embodiments, an analyte sensor may be positioned in contactwith interstitial fluid to detect the level of glucose, which detectedglucose may be used to infer the glucose level in the patient'sbloodstream. Analyte sensors may be insertable into a vein, artery, orother portion of the body containing fluid. Embodiments of the analytesensors of the subject disclosure may be configured for monitoring thelevel of the analyte over a time period which may range from minutes,hours, days, weeks, or longer.

Of interest are analyte sensors, such as glucose sensors, that arecapable of in vivo detection of an analyte for about one hour or more,e.g., about a few hours or more, e.g., about a few days of more, e.g.,about three or more days, e.g., about five days or more, e.g., aboutseven days or more, e.g., about several weeks or at least one month.Future analyte levels may be predicted based on information obtained,e.g., the current analyte level at time t₀, the rate of change of theanalyte, etc. Predictive alarms may notify the user of predicted analytelevels that may be of concern prior in advance of the analyte levelreaching the future level. This enables the user an opportunity to takecorrective action. Embodiments include transmission of the acquired realtime analyte information on-demand from the user (using for example, thereader device/receiver unit positioned in close proximity to the lowprofile on-body patch device), storage of the acquired real time analyteinformation, and subsequent transmission based on retrieval from thestorage device (such as a memory device).

FIG. 1 shows a data monitoring and management system such as, forexample, an analyte (e.g., glucose) monitoring system in accordance withcertain embodiments of the present disclosure. Embodiments of thesubject disclosure are described primarily with respect to glucosemonitoring devices and systems, and methods of glucose detection, forconvenience only and such description is in no way intended to limit thescope of the disclosure. It is to be understood that the analytemonitoring system may be configured to monitor a variety of analytes atthe same time or at different times.

Analytes that may be monitored include, but are not limited to, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin,creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glucose,glutamine, growth hormones, hormones, ketones, lactate, peroxide,prostate-specific antigen, prothrombin, RNA, thyroid stimulatinghormone, and troponin. The concentration of drugs, such as, for example,antibiotics (e.g., gentamicin, vancomycin, and the like), digitoxin,digoxin, drugs of abuse, theophylline, and warfarin, may also bemonitored. In those embodiments that monitor more than one analyte, theanalytes may be monitored at the same or different times.

Referring to FIG. 1, the analyte monitoring system 100 includes a sensor101, a data processing unit (e.g., sensor electronics) 102 connectableto the sensor 101, and a primary receiver unit 104 which is configuredto communicate with the data processing unit 102 via a communicationlink 103. In aspects of the present disclosure, the sensor 101 and thedata processing unit (sensor electronics) 102 may be configured as asingle integrated assembly 110. In certain embodiments, the integratedsensor and sensor electronics assembly 110 may be configured as anon-body patch device. In such embodiments, the on-body patch device maybe configured for, for example, RFID or RF communication with a readerdevice/receiver unit.

In certain embodiments, the primary receiver unit 104 may be furtherconfigured to transmit data to a data processing terminal 105 toevaluate or otherwise process or format data received by the primaryreceiver unit 104. The data processing terminal 105 may be configured toreceive data directly from the data processing unit 102 via acommunication link which may optionally be configured for bi-directionalcommunication. Further, the data processing unit 102 may include atransmitter or a transceiver to transmit and/or receive data to and/orfrom the primary receiver unit 104, the data processing terminal 105 oroptionally the secondary receiver unit 106.

Also shown in FIG. 1 is an optional secondary receiver unit 106 which isoperatively coupled to the communication link and configured to receivedata transmitted from the data processing unit 102. The secondaryreceiver unit 106 may be configured to communicate with the primaryreceiver unit 104, as well as the data processing terminal 105. Thesecondary receiver unit 106 may be configured for bi-directionalwireless communication with each of the primary receiver unit 104 andthe data processing terminal 105. As discussed in further detail below,in certain embodiments the secondary receiver unit 106 may be ade-featured receiver as compared to the primary receiver unit 104, i.e.,the secondary receiver unit 106 may include a limited or minimal numberof functions and features as compared with the primary receiver unit104. As such, the secondary receiver unit 106 may include a smaller (inone or more, including all, dimensions), compact housing or embodied ina device such as a wrist watch, arm band, etc., for example.Alternatively, the secondary receiver unit 106 may be configured withthe same or substantially similar functions and features as the primaryreceiver unit 104. The secondary receiver unit 106 may include a dockingportion to be mated with a docking cradle unit for placement by, e.g.,the bedside for night time monitoring, and/or bi-directionalcommunication device.

Only one sensor 101, data processing unit 102 and data processingterminal 105 are shown in the embodiment of the analyte monitoringsystem 100 illustrated in FIG. 1. However, it will be appreciated by oneof ordinary skill in the art that the analyte monitoring system 100 mayinclude more than one sensor 101 and/or more than one data processingunit 102, and/or more than one data processing terminal 105. Multiplesensors may be positioned in a patient for analyte monitoring at thesame or different times. In certain embodiments, analyte informationobtained by a first positioned sensor may be employed as a comparison toanalyte information obtained by a second sensor. This may be useful toconfirm or validate analyte information obtained from one or both of thesensors. Such redundancy may be useful if analyte information iscontemplated in critical therapy-related decisions. In certainembodiments, a first sensor may be used to calibrate a second sensor.

The analyte monitoring system 100 may be a continuous monitoring system,or semi-continuous, or a discrete monitoring system. In amulti-component environment, each component may be configured to beuniquely identified by one or more of the other components in the systemso that communication conflict may be readily resolved between thevarious components within the analyte monitoring system 100. Forexample, unique IDs, communication channels, and the like, may be used.

In certain embodiments, the sensor 101 is physically positioned in or onthe body of a user whose analyte level is being monitored. The sensor101 may be configured to at least periodically sample the analyte levelof the user and convert the sampled analyte level into a correspondingsignal for transmission by the data processing unit 102.

The data processing unit 102 is coupleable to the sensor 101 so thatboth devices are positioned in or on the user's body, with at least aportion of the analyte sensor 101 positioned transcutaneously. The dataprocessing unit 102 in certain embodiments may include a portion of thesensor 101 (proximal section of the sensor in electrical communicationwith the data processing unit 102) which is encapsulated within or onthe printed circuit board of the data processing unit 102 with, forexample, potting material or other protective material. The dataprocessing unit 102 performs data processing functions, where suchfunctions may include but are not limited to, filtering and encoding ofdata signals, each of which corresponds to a sampled analyte level ofthe user, for transmission to the primary receiver unit 104 via thecommunication link 103. In one embodiment, the sensor 101 or the dataprocessing unit 102 or a combined sensor/data processing unit may bewholly implantable under the skin layer of the user.

In one aspect, the primary receiver unit 104 may include an analoginterface section including an RF receiver and an antenna that isconfigured to communicate with the data processing unit 102 via thecommunication link 103, and a data processing section for processing thereceived data from the data processing unit 102 such as data decoding,error detection and correction, data clock generation, and/or data bitrecovery.

In operation, the primary receiver unit 104 in certain embodiments isconfigured to synchronize with the data processing unit 102 to uniquelyidentify the data processing unit 102, based on, for example, anidentification information of the data processing unit 102, andthereafter, to periodically receive signals transmitted from the dataprocessing unit 102 associated with the monitored analyte levelsdetected by the sensor 101. That is, when operating in the CGM mode, thereceiver unit 104 in certain embodiments is configured to automaticallyreceive time spaced analyte related data packets from the analytesensor/sensor electronics when the communication link (e.g., RF range)is maintained between these components.

Referring again to FIG. 1, the data processing terminal 105 may includea personal computer, a portable data processing devices or computerssuch as a laptop computer or a handheld device (e.g., personal digitalassistants (PDAs), communication devices such as a cellular phone (e.g.,a multimedia and Internet-enabled mobile phone such as an iPhone, aBlackberry device, a Palm device such as Palm Pre, Treo, or similarphone), mp3 player, pager, and the like), drug delivery device, each ofwhich may be configured for data communication with the receiver via awired or a wireless connection. Additionally, the data processingterminal 105 may further be connected to a data network (not shown) forstoring, retrieving, updating, and/or analyzing data corresponding tothe detected analyte level of the user.

The data processing terminal 105 may include an infusion device such asan insulin infusion pump or the like, which may be configured toadminister insulin to patients, and which may be configured tocommunicate with the primary receiver unit 104 for receiving, amongothers, the measured analyte level. Alternatively, the primary receiverunit 104 may be configured to integrate an infusion device therein sothat the primary receiver unit 104 is configured to administer insulin(or other appropriate drug) therapy to patients, for example, foradministering and modifying basal profiles, as well as for determiningappropriate boluses for administration based on, among others, thedetected analyte levels received from the data processing unit 102. Aninfusion device may be an external device or an internal device (whollyimplantable in a user).

In particular embodiments, the data processing terminal 105, which mayinclude an insulin pump, may be configured to receive the analytesignals from the data processing unit 102, and thus, incorporate thefunctions of the primary receiver unit 104 including data processing formanaging the patient's insulin therapy and analyte monitoring. Incertain embodiments, the communication link 103 as well as one or moreof the other communication interfaces shown in FIG. 1 may use one ormore of an RF communication protocol, an infrared communicationprotocol, a Bluetooth enabled communication protocol, an 802.11xwireless communication protocol, or an equivalent wireless communicationprotocol which would allow secure, wireless communication of severalunits (for example, per HIPPA requirements) while avoiding potentialdata collision and interference.

As described in aspects of the present disclosure, the analytemonitoring system may include an on-body patch device with a thinprofile that can be worn on the arm or other locations on the body (andunder clothing worn by the user or the patient), the on-body patchdevice including an analyte sensor and circuitry and components foroperating the sensor and processing and storing signals received fromthe sensor as well as for communication with the reader device. Forexample, one aspect of the on-body patch device may include electronicsto sample the voltage signal received from the analyte sensor in fluidcontact with the body fluid, and to process the sampled voltage signalsinto the corresponding glucose values and/or store the sampled voltagesignal as raw data.

In certain embodiments, the on-body patch device includes an antennasuch as a loop antenna to receive RF power from the an external devicesuch as the reader device/receiver unit described above, electronics toconvert the RF power received via the antenna into DC (direct current)power for the on-body patch device circuitry, communication module orelectronics to detect commands received from the reader device, andcommunication component to transmit data to the reader device, a lowcapacity battery for providing power to sensor sampling circuitry (forexample, the analog front end circuitry of the on-body patch device insignal communication with the analyte sensor), one or more non-volatilememory or storage device to store data including raw signals from thesensor or processed data based on the raw sensor signals. Morespecifically, in the on operation demand mode, the on body patch devicein certain embodiments is configured to transmit real time analyterelated data and/or stored historical analyte related data when withinthe RF power range of the reader device. As such, when the reader deviceis removed of positioned out of range relative to the on body patchdevice, the on body patch device may no longer transmit the analyterelated data.

In certain embodiments, a data processing module/terminal may beprovided in the analyte monitoring system that is configured to operateas a data logger, interacting or communicating with the on-body patchdevice by, for example, transmitting requests for analyte levelinformation to the on-body patch device, and storing the responsiveanalyte level information received from the on-body patch device in oneor more memory components of the data processing module. Further, dataprocessing module may be configured as a compact on-body relay device torelay or retransmit the received analyte level information from theon-body patch device to the reader device/receiver unit or the remoteterminal or both. The data processing module in one aspect may bephysically coupled to the on-body patch device, for example, on a singleadhesive patch on the skin surface of the patient. Alternatively, thedata processing module may be positioned close to but not in contactwith the on-body patch device. For example, when the on-body patchdevice is positioned on the abdomen of the patient, the data processingmodule may be worn on a belt of the patient or the user, such that thedesired close proximity or predetermined distance of approximately 1-5inches (or about 1-10 inches, for example, or more) between the on-bodypatch device and the data processing module may be maintained.

The various processes described above including the processes operatingin the software application execution environment in the analytemonitoring system including the on-body patch device, the reader device,data processing module and/or the remote terminal performing one or moreroutines described above may be embodied as computer programs developedusing an object oriented language that allows the modeling of complexsystems with modular objects to create abstractions that arerepresentative of real world, physical objects and theirinterrelationships. The software required to carry out the inventiveprocess, which may be stored in a memory or storage device of thestorage unit of the various components of the analyte monitoring systemdescribed above in conjunction to the Figures including the on-bodypatch device, the reader device, the data processing module, variousdescribed communication devices, or the remote terminal may be developedby a person of ordinary skill in the art and may include one or morecomputer program products.

In one embodiment, an apparatus for bi-directional communication with ananalyte monitoring system may comprise a storage device having storedtherein one or more routines, a processing unit operatively coupled tothe storage device and configured to retrieve the stored one or moreroutines for execution, a data transmission component operativelycoupled to the processing unit and configured to transmit data based atleast in part on the one or more routines executed by the processingunit, and a data reception component operatively coupled to theprocessing unit and configured to receive analyte related data from aremote location and to store the received analyte related data in thestorage device for retransmission, wherein the data transmissioncomponent is programmed to transmit a query to a remote location, andfurther wherein the data reception component receives the analyterelated data from the remote location in response to the transmittedquery when one or more electronics in the remote location transitionsfrom an inactive state to an active state upon detection of the queryfrom the data transmission component.

FIG. 2 illustrates a data monitoring and management system for real timeglucose measurement data acquisition and processing in one aspect of thepresent disclosure. More specifically, as shown in FIG. 2, the on-bodypatch device 211 including sensor electronics coupled to an analytesensor 250 is positioned on a skin surface 210 of a patient or a user.In one aspect, an introducer mechanism may be provided, as discussed infurther detail below in conjunction with FIGS. 12A-12G, for thetranscutaneous placement of the analyte sensor 250 such that when theon-body patch device 211 is positioned on the skin surface, a portion ofthe sensor 250 is inserted through the skin surface and in fluid contactwith a body fluid of the patient or the user under the skin layer 210.

The introducer mechanism may be fully or partially automated, forexample with a trigger mechanism, or may be fully or partially manualsuch that the sensor 250 is positioned transcutaneously by a manualoperation of the user. That is, in one aspect, the on-body patch device211 may include an introducer needle and/or lumen (and/or catheter)which may guide the sensor 250 during the insertion process through theskin layer 210. In a further aspect, the placement of the on-body patchdevice 211 on the skin layer 210 includes the initial piercing of theskin layer 210 with a force applied on the on-body patch device 211 inconjunction with the on-body patch device 211 placement on the skinlayer 210, effectively driving the sensor 250 (and/or the introducer)through the skin layer 210. Within the scope of the present disclosure,a mechanism (such as a spring, for example) may be provided within theon-body patch device 211 or alternatively, in the introducer incooperation with the on-body patch device 211, to withdraw theintroducer needle after the sensor 250 has been positioned in fluidcontact with the body fluid. In certain other embodiments, a lumen maybe provided, with the analyte sensor 250 provided within the hollowcavity of the lumen for insertion, and maintained in position with theon-body patch device 211 during the time period that the on-body patchdevice 211 is worn on the skin layer 210.

Referring back to FIG. 2, as shown, when the reader device/receiver unit220 is positioned or placed in close proximity and within apredetermined range of the on-body patch device 211, the RF power supplyin the reader device/receiver unit 220 may be configured to provide thenecessary power to operate the electronics in the on-body patch device211, and the on-body patch device 211 may be configured to, upondetection or the RF power from the reader device/receiver unit 220,perform preprogrammed routines including, for example, transmitting oneor more signals 240 to the reader device/receiver unit 220 indicative ofthe sampled analyte level measured by the analyte sensor 250.

In certain embodiments, the reader device/receiver unit 220 may includean RF power switch that is user activatable or activated uponpositioning within a predetermined distance from the on body patchdevice 211 to turn on the analyte sensor in the on body patch device211. That is, using the RF signal, the analyte sensor coupled to thesensor electronics in the on-body patch device 211 may be initialized oractivated. In another embodiment, a passive RFID function may beprovided or programmed such that upon receiving a “turn on” signalwhich, when authenticated, will turn on the electronic power switch thatactivates the on-body patch device 211. That is, the passive RFIDconfiguration may include drawing energy from the RF field radiated fromthe reader device/receiver unit 220 so as to prompt for and/or detectthe “turn on” signal which, upon authentication, activates the on bodypatch device 211.

In one embodiment, communication and/or RF power transfer between thereader device/receiver unit 220 and the on-body patch device 211 may beautomatically initiated when the reader device/receiver unit 220 isplaced in close proximity to the on-body patch device 211 as discussedabove. Alternatively, the reader device/receiver unit 220 may beconfigured such that user activation, such as data request initiationand subsequent confirmation by the user using, for example, the display222 and/or input components 221 of the reader device/receiver unit 220,may be required prior to the initiation of communication and/or RF powertransfer between the reader device/receiver unit 220 and the on-bodypatch device 211. In a further embodiment, the reader device/receiverunit 220 may be user configurable between multiple modes, such that theuser may choose whether the communication between the readerdevice/receiver unit 220 and on-body patch device 211 is performedautomatically or requires a user activation and/or confirmation.

As further shown in FIG. 2, the reader device/receiver unit 220 mayinclude display 222 or output component to provide output indication tothe user or the patient, including, for example, the correspondingglucose level measurement. The display 222 of the reader device/receiverunit 220 may be additionally configured to provide the functionalitiesof a user interface to present other information such as alarm or alertnotification to the user. In one aspect, the reader device/receiver unit220 may include other output components such as a speaker, vibratoryoutput component and the like to provide audible and/or vibratory outputindication to the user in addition to the visual output indicationprovided on the display 222. Moreover, the reader device/receiver unit220 may also include one or more input components 221 (such as, forexample, push buttons, switches, capacitive sliders, jog wheels, etc.)for receiving input commands or information from the user or the patientby operation of the input components 221. In one embodiment, the display222 and the input component 221 may be integrated into a singlecomponent, for example as a touch screen display. In such an embodiment,the user may be able to manipulate the reader device/receiver unit 220by utilizing a set of pre-programmed motion commands, including, but notlimited to, single or double tapping the display, dragging a finger orinstrument across the display, motioning multiple fingers toward oneanother, motioning multiple fingers away from one another, etc. Otherembodiments include the use of “soft buttons”, whereby the inputcomponents 221 correspond to dynamic menus on the display 222 to controlfeatures and operation of the reader device/receiver unit 220. In yetanother embodiment, the input component 221 may include a microphone andthe reader device/receiver unit 220 may include software configured toanalyze audio input received from the microphone, such that functionsand operation of the reader device/receiver unit 220 may be controlledaudibly by the user or patient.

As discussed, some or all of the electronics in the on-body patch device211 in one embodiment may be configured to rely on the RF power receivedfrom the reader device/receiver unit 220 to perform analyte dataprocessing and/or transmission of the processed analyte information tothe reader device/receiver unit 220. That is, the on-body patch device211 may be discreetly worn on the body of the user or the patient, andunder clothing, for example, and when desired, by positioning the readerdevice/receiver unit 220 within a predetermined distance from theon-body patch device 211, real time glucose level information may bereceived by the reader device/receiver unit 220. This routine may berepeated as desired by the patient (or on-demand, for example) todetermine glucose levels at any time during the time period that theon-body patch device 211 is worn by the user or the patient.

Referring still to FIG. 2, also shown are a data processingmodule/terminal 260 and a remote terminal 270. In one aspect, dataprocessing module 260 may include a stand alone device configured forbi-directional communication to communicate with the on-body patchdevice 211, the reader device/receiver unit 220 and/or the remoteterminal 270. More specifically, data processing module 260 may includeone or more microprocessors or similar data processing componentsconfigured to execute one or more software routines for communication,as well as data storage and retrieval to and from one or more memorycomponents provided in the housing of the data processing module 260.

The data processing module 260 in one embodiment may be configured tocommunicate with the on-body patch device 211 in a similar manner as thereader device/receiver unit 220 and may include communication componentssuch as antenna, power supply and memory, among others, for example, toallow provision of RF power to the on-body patch device 211 or torequest or prompt the on-body patch device 211 to send the currentanalyte related data and optionally other stored analyte related data.The data processing module 260 may be configured to interact with theon-body patch device 211 in a similar manner as the readerdevice/receiver unit 220 such that the data processing module 260 may bepositioned within a predetermined distance from the on-body patch device211 for communication with the on-body patch device 211.

In one aspect, the on-body patch device 211 and the data processingmodule 260 may be positioned on the skin surface of the user or thepatient within the predetermined distance of each other (for example,within approximately 5 inches or less) such that the communicationbetween the on-body patch device 211 and the data processing module 260is maintained. In a further aspect, the housing of the data processingmodule 260 may be configured to couple to or cooperate with the housingof the on-body patch device 211 such that the two devices are combinedor integrated as a single assembly and positioned on the skin surface.

Referring again to FIG. 2, the data processing module 260 may beconfigured or programmed to prompt or ping the on-body patch device 211at a predetermined time interval such as once every minute, or onceevery five minutes or once every 30 minutes or any other suitable ordesired programmable time interval to request analyte related data fromthe on-body patch device 211 which is received and is stored in one ormore memory devices or components of the data processing module 260. Inanother embodiment, the data processing module 260 is configured toprompt or ping the on-body patch device 211 when desired by the patientor the user on-demand, and not based on a predetermined time interval.In yet another embodiment, the data processing module 260 is configuredto prompt or ping the on-body patch device 211 when desired by thepatient or the user upon request only after a programmable time intervalhas elapsed. For example, in certain embodiments, if the user does notinitiate communication within a programmed time period, such as, forexample 5 hours from last communication (or 10 hours from the lastcommunication), the data processing module 260 may by programmed toautomatically ping or prompt the on-body patch device 211 oralternatively, initiate an alarm function to notify the user that anextended period of time has elapsed since the last communication betweenthe data processing module 260 and the on-body patch device 211. In thismanner, users, healthcare providers, or the patient may program orconfigure the data processing module 260 to provide certain compliancewith analyte monitoring regimen, so that frequent determination ofanalyte levels is maintained or performed by the user. Similarfunctionalities may be provided or programmed in the receiver unit orthe reader device in certain embodiments.

As further shown in FIG. 2, the data processing module 260 in one aspectmay be configured to transmit the stored data received from the on-bodypatch device 211 to the reader device/receiver unit 220 whencommunication between the data processing module 260 and the readerdevice/receiver unit 220 is established. More specifically, in additionto RF antenna and RF communication components described above, dataprocessing module 260 may include components to communicate using one ormore wireless communication protocols such as, for example, but notlimited to, infrared (IR) protocol, Bluetooth protocol, Zigbee protocol,and 802.11 wireless LAN protocol. Additional description ofcommunication protocols including those based on Bluetooth protocoland/or Zigbee protocol can be found in U.S. Patent Publication No.2006/0193375 incorporated herein by reference for all purposes. The dataprocessing module 260 may further include communication ports, driversor connectors to establish wired communication with one or more of thereader device/receiver unit 220, on-body patch device 211, or the remoteterminal 270 including, for example, but not limited to USB connectorand/or USB port, Ethernet connector and/or port, FireWire connectorand/or port, or RS-232 port and/or connector.

In one aspect, the data processing module 260 may be configured tooperate as a data logger configured or programmed to periodicallyrequest or prompt the on-body patch device 211 to transmit the analyterelated information, and to store the received information for laterretrieval or subsequent transmission to the reader device/receiver unit220 or to the remote terminal 270 or both, for further processing andanalysis. Further, the memory or storage component in the dataprocessing module 260 may be sufficiently large to store or retainanalyte level information over an extended time period, for example,coinciding with the usage life of the analyte sensor 250 in the on-bodypatch device 211. In this manner, the analyte monitoring systemdescribed above in conjunction with FIGS. 1 and 2 may be configured tooperate in a CGM (continuous glucose monitoring) mode such that acontinuous, time spaced monitored analyte level may be received from theon-body patch device 211 and stored in the data processing module 260.The stored data in the data processing module 260 may be subsequentlyprovided to or transmitted to the reader device/receiver unit 220, theremote terminal 270 or the like for further analysis such as identifyingfrequency of periods of glycemic level excursions over the monitoredtime period to improve or enhance therapy related decisions. Using thisinformation, the doctor, healthcare provider or the patient may adjustor recommend modification to the diet, daily habits and routines such asexercise, and the like.

In a further aspect, the functionalities of the data processing module260 may be configured or incorporated into a memory device such as an SDcard, microSD card, compact flash card, XD card, Memory Stick card,Memory Stick Duo card, or USB memory stick/device including softwareprogramming resident in such devices to execute upon connection to therespective one or more of the on-body patch device 211, the remoteterminal 270 or the reader device/receiver unit 220. In a furtheraspect, the functionalities of the data processing module 260, includingexecutable software and programming, may be provided to a communicationdevice such as a mobile telephone including, for example, iPhone,iTouch, Blackberry device, Palm based device (such as Palm Pre, Treo,Treo Pro, Centro), personal digital assistants (PDAs) or any othercommunication enabled operating system (such as Windows or Androidoperating systems) based mobile telephones as a downloadable applicationfor execution by the downloading communication device. To this end, theremote terminal 270 as shown in FIG. 2 may include a personal computer,or a server terminal that is configured to provide the executableapplication software to the one or more of the communication devicesdescribed above when communication between the remote terminal 270 andthe devices are established. In still a further aspect, the executabledownloadable application may be provided over-the-air (OTA) as an OTAdownload such that wired connection to the remote terminal 270 is notnecessary. In this configuration, the executable application may beautomatically downloaded as an available download to the communicationdevice, and depending upon the configuration of the communicationdevice, installed on the device for use automatically, or based on userconfirmation or acknowledgement on the communication device to executethe installation of the application.

Depending upon the user setting or configuration on the communicationdevice, the downloaded application may be programmed or customized usingthe user interface of the respective communication device (screen,keypad, and the like) to establish or program the desired settings suchas hyperglycemia alarm, hypoglycemia alarm, sensor replacement alarm,sensor calibration alarm, or any other alarm or alert conditions as maybe desired by the user. Moreover, the programmed notification settingson the communication device may be output using the output components ofthe respective communication devices, such as speaker, vibratory outputcomponent, or visual output/display. As a further example, thecommunication device may be provided with programming and applicationsoftware to communicate with the on-body patch device 211 such that afrequency or periodicity of data acquisition is established. In thismanner, the communication device may be configured to convenientlyreceive analyte level information from the on-body patch device 211 atpredetermined time periods such as, for example, but not limited to onceevery minute, once every five minutes, or once every 10 or 15 minutes,and store the received information, as well as to provide real timedisplay of the monitored or received analyte level information and otherrelated output display such as trend indication of the analyte level(for example, based on the received analyte level information),projection of future analyte levels based on the analyte trend, and anyother desired or appropriate warning indication or notification to theuser or the patient.

Information, such as trend information, for example, may be output onone or more of the reader device/receiver unit 220, data processingmodule 260, remote terminal 270, or any other connected device withoutput capabilities. Trend, and other, information may be output on adisplay unit of a device, for example the display 222 of the readerdevice/receiver unit 220. Trend information may be displayed as, forexample, a graph (such as a line graph) to indicate to the user orpatient the current, historical, and predicted future analyte levels asmeasured and predicted by the analyte monitoring system. Trendinformation may also be displayed as trend arrows, indicating whetherthe analyte level is increasing or decreasing as well as theacceleration or deceleration of the increase or decrease in analytelevel. This information may be utilized by the user or patient todetermine any necessary corrective actions to ensure the analyte levelremains within an acceptable and/or clinically safe range. Other visualindicators, including colors, flashing, fading, etc., as well as audioindicators including a change in pitch, volume, or tone of an audiooutput and/or vibratory or other tactile indicators may also beincorporated into the display of trend data as means of notifying theuser or patient of the current level and/or direction and/or rate ofchange of the level of the monitored analyte.

Additionally, when integrated with the functionalities of the dataprocessing module 260, the communication devices described above may beprogrammed to operate in the optional CGM mode to receive the timespaced monitored analyte level information from the on-body patch device211.

Referring back to the remote terminal 270 of FIG. 2, in one aspect,software updates such as software patches, firmware updates or driverupgrades, among others, to the reader device/receiver unit 220, on-bodypatch device 211 or the data processing module 260 may be provided bythe remote terminal 270 when communication between the remote terminal270 and the reader device/receiver unit 220 and/or the data processingmodule 260 is established. In still another aspect, software upgrades,programming changes or modification to the on-body patch device 211 maybe received from the remote terminal 270 by one or more of the readerdevice/receiver unit 220 or the data processing module 260, andthereafter, provided to the on-body patch device 211 by the readerdevice/receiver unit 220 or the data processing module 260.

FIG. 3 is a block diagram of a receiver/monitor unit such as that shownin FIG. 1 in accordance with certain embodiments. The primary receiverunit 104 (FIG. 1) includes one or more of: a blood glucose test stripinterface 301, an RF receiver 302, an input 303, a temperature detectionsection 304, and a clock 305, each of which is operatively coupled to aprocessing and storage section 307. The primary receiver unit 104 alsoincludes a power supply 306 operatively coupled to a power conversionand monitoring section 308. Further, the power conversion and monitoringsection 308 is also coupled to the receiver processor 307. Moreover,also shown are a receiver serial communication section 309, and anoutput 310, each operatively coupled to the processing and storage unit307. The receiver may include user input and/or interface components ormay be free of user input and/or interface components.

In certain embodiments, the test strip interface 301 includes a glucoselevel testing portion to receive a blood (or other body fluid sample)glucose test or information related thereto. For example, the interfacemay include a test strip port to receive a glucose test strip. Thedevice may determine the glucose level of the test strip, and optionallydisplay (or otherwise notice) the glucose level on the output 310 of theprimary receiver unit 104. Any suitable test strip may be employed,e.g., test strips that only require a very small amount (e.g., onemicroliter or less, e.g., about 0.5 microliter or less, e.g., about 0.1microliter or less), of applied sample to the strip in order to obtainaccurate glucose information, e.g. FreeStyle® or Precision® bloodglucose test strips and systems from Abbott Diabetes Care Inc. Glucoseinformation obtained by the in vitro glucose testing device may be usedfor a variety of purposes, computations, etc. For example, theinformation may be used to calibrate sensor 101, confirm results of thesensor 101 to increase the confidence thereof (e.g., in instances inwhich information obtained by sensor 101 is employed in therapy relateddecisions), etc.

In one aspect, the RF receiver 302 is configured to communicate, via thecommunication link 103 (FIG. 1) with the data processing unit (sensorelectronics) 102, to receive encoded data from the data processing unit102 for, among others, signal mixing, demodulation, and other dataprocessing. The input 303 of the primary receiver unit 104 is configuredto allow the user to enter information into the primary receiver unit104 as needed. In one aspect, the input 303 may include keys of akeypad, a touch-sensitive screen, and/or a voice-activated input commandunit, and the like. The temperature monitor section 304 may beconfigured to provide temperature information of the primary receiverunit 104 to the processing and control section 307, while the clock 305provides, among others, real time or clock information to the processingand storage section 307.

Each of the various components of the primary receiver unit 104 shown inFIG. 3 is powered by the power supply 306 (or other power supply) which,in certain embodiments, includes a battery. Furthermore, the powerconversion and monitoring section 308 is configured to monitor the powerusage by the various components in the primary receiver unit 104 foreffective power management and may alert the user, for example, in theevent of power usage which renders the primary receiver unit 104 insub-optimal operating conditions. The serial communication section 309in the primary receiver unit 104 is configured to provide abi-directional communication path from the testing and/or manufacturingequipment for, among others, initialization, testing, and configurationof the primary receiver unit 104.

Serial communication section 104 can also be used to upload data to acomputer, such as time-stamped blood glucose data. The communicationlink with an external device (not shown) can be made, for example, bycable (such as USB or serial cable), infrared (IR) or RF link. Theoutput/display 310 of the primary receiver unit 104 is configured toprovide, among others, a graphical user interface (GUI), and may includea liquid crystal display (LCD) for displaying information. Additionally,the output/display 310 may also include an integrated speaker foroutputting audible signals as well as to provide vibration output ascommonly found in handheld electronic devices, such as mobiletelephones, pagers, etc. In certain embodiments, the primary receiverunit 104 also includes an electro-luminescent lamp configured to providebacklighting to the output 310 for output visual display in dark ambientsurroundings.

Referring back to FIG. 3, the primary receiver unit 104 may also includea storage section such as a programmable, non-volatile memory device aspart of the processor 307, or provided separately in the primaryreceiver unit 104, operatively coupled to the processor 307. Theprocessor 307 may be configured to perform Manchester decoding (or otherprotocol(s)) as well as error detection and correction upon the encodeddata received from the data processing unit 102 via the communicationlink 103.

In further embodiments, the data processing unit 102 and/or the primaryreceiver unit 104 and/or the secondary receiver unit 105, and/or thedata processing terminal/infusion section 105 may be configured toreceive the blood glucose value wirelessly over a communication linkfrom, for example, a blood glucose meter. In further embodiments, a usermanipulating or using the analyte monitoring system 100 (FIG. 1) maymanually input the blood glucose value using, for example, a userinterface (for example, a keyboard, keypad, voice commands, and thelike) incorporated in the one or more of the data processing unit 102,the primary receiver unit 104, secondary receiver unit 105, or the dataprocessing terminal/infusion section 105.

Additional detailed descriptions are provided in U.S. Pat. Nos.5,262,035; 5,264,104; 5,262,305; 5,320,715; 5,593,852; 6,175,752;6,650,471; 6,746,582, 6,284,478, 7,299,082, and in application Ser. No.10/745,878 filed Dec. 26, 2003 titled “Continuous Glucose MonitoringSystem and Methods of Use”, and in application Ser. No. 11/060,365 filedFeb. 16, 2005 titled “Method and System for Providing Data Communicationin Continuous Glucose Monitoring And Management System” each of which isincorporated herein by reference.

FIG. 4 is a block diagram of a reader device/receiver unit such as thatshown in FIG. 2 in one aspect of the present disclosure. Referring toFIG. 4, in one aspect the reader device/receiver unit includes a controlunit 410, such as one or more microprocessors, operatively coupled to adisplay 430 and a user interface 420. The reader device/receiver unitmay also include one or more data communication ports such as USB port(or connector) 470 or RS-232 port 450 (or any other wired communicationports) for data communication with other devices such as a personalcomputer, a server, a mobile computing device, a mobile telephone, apager, or other handheld data processing devices including smart phonessuch as Blackberry, iPhone and Palm based mobile devices, with datacommunication and processing capabilities including data storage andoutput.

Referring to FIG. 4, a power supply 440, such as one or more batteries,is also provided and operatively coupled to the control unit 410 andconfigured to provide the necessary power to the reader device/receiverunit for operation. In addition, referring still again to FIG. 4, thereader device/receiver unit may include a loop antenna 481 such as a 433MHz (or other equivalent) loop antenna coupled to a receiver processor480 (which may include a 433 MHz receiver chip, for example) forwireless communication with the sensor electronics in the on-body patchdevice/sensor data processing unit. Additionally, a primary inductiveloop antenna 491 is provided and coupled to a squarewave driver 490which is operatively coupled to the control unit 410.

Referring still to FIG. 4, the reader device/receiver unit of theanalyte monitoring system may include a strip port 460 configured toreceive an in vitro test strip, the strip port 460 coupled to thecontrol unit 410, and further, where the control unit 410 includesprogramming to process the sample on the in vitro test strip which isreceived in the strip port 460. Furthermore, within the scope of thepresent disclosure some of the components of the reader device/receiverunit shown in FIG. 4 may be integrated as a single component such as theuser interface 420 and the display 430 may be configured as a singletouch sensitive display which may be configured to include soft buttonsof the display itself, operable by the user or the patient for providinginput commands or information to the reader device.

In one aspect, the reader device/receiver unit of the analyte monitoringsystem described herein may be configured to include a compact formfactor, similar to a USB memory device, where the USB port 470 may beconfigured as a USB connector for insertion or connection to a USB porton another device such as a personal computing device or the like. Suchcompact form factor may include some or all of the components of thereader device/receiver unit described above.

FIG. 5 is an exemplary schematic of an on-body patch device including anintegrated sensor and sensor electronics assembly for use in the analytemonitoring systems of FIGS. 1 and 2 in one aspect of the presentdisclosure. As shown in FIG. 5, the integrated sensor and sensorelectronics assembly/on-body patch device of the analyte monitoringsystem, in one aspect, may include a loop antenna 520 for transmittingthe analyte related data to the reader device/receiver unit and further,an inductive power loop antenna 530 for processing the RF power from thereader device/receiver unit, and including converting the RF power tocorresponding DC power for the operation of the electronics of theon-body patch device. In this manner, in one aspect of the presentdisclosure, the on-body patch device may be configured to operate as apassive data transmitter, adopting inductive coupling power without aseparate power supply or battery for data transmission. Furthermore, theon-body patch device in one aspect does not require a mechanism to turnthe device in operational mode nor to deactivate or turn off the on-bodypatch device. That is, the on-body patch device may be configured toenter an active or operational mode when it detects the RF power fromthe reader device. Further shown in FIG. 5 is a plurality of supercapacitors C1, C2 coupled to the inductive power loop antenna 530 andthe controller 510. Referring still to FIG. 5, the controller 510 may beprovided on a printed circuit board assembly including the loop antenna520, thermistor (not shown), analyte sensor contact pads for coupling tothe electrodes of the sensor 540, one or more storage devices such asnon-volatile memory (not shown), and other discrete components. Incertain aspects, the printed circuit board assembly may be partially orfully encapsulated with, for example, potting material.

FIG. 6 is a block diagram of the integrated sensor and sensorelectronics assembly for use in the analyte monitoring systems of FIGS.1 and 2 in another aspect of the present disclosure. Referring to FIG.6, in certain aspects of the present disclosure, the on-body patchdevice includes a control unit 610 (such as, for example but not limitedto, one or more microprocessors, and/or application specific integratedcircuits (ASICs)), operatively coupled to analog front end circuitry 670to process signals such as raw voltage or current signals received fromthe sensor 680. Also shown in FIG. 6 is a memory 620 operatively coupledto the control unit 610 for storing data and/or software routines forexecution by the control unit 610. That is, the control unit 610 may beconfigured to access the data or routines stored in the memory 620 toupdate, store or replace information in the memory 620, in addition toretrieving one or more stored routines for execution. Also shown in FIG.6 is a power supply 660 which, in certain embodiments, provides power tothe electronics of the on-body patch device for operation, under thecontrol of the control unit 610, to process signals from the sensor 680and to store the processed sensor data for subsequent transmission tothe reader device/receiver unit when prompted or pinged by the readerdevice/receiver unit for transmission of the stored data in addition tothe real time analyte level data. As discussed above, in certainembodiments, the on-body patch device does not include the power supply660 and is configured to rely upon the RF power from the reader device.

Additionally, an optional output unit 650 is provided to the on-bodypatch device as shown in FIG. 6. In certain embodiments, the output unit650 may include an LED indicator, for example, to alert the user or thepatient of one or more predetermined conditions associated with theoperation of the on-body patch device and/or the determined analytelevel. For example, in one aspect, the on-body patch device may beprogrammed or configured to provide a visual indication to notify theuser of one or more predetermined operational conditions of the on-bodypatch device. The one or more predetermined operational conditions maybe configured by the user or the patient or the healthcare provider, sothat certain conditions are associated with an output indication on theon-body patch device. By way of nonlimiting example, the on-body patchdevice may be programmed to assert a notification using the LEDindicator on the on-body patch device when signals from the sensor 680are indicated to be beyond a programmed acceptable range (based on onesampled sensor data point, or multiple sensor data points), potentiallyindicating a health risk condition such as hyperglycemia orhypoglycemia, or the onset of such conditions. With such prompt orindication, the user or the patient may be timely informed of suchpotential condition, and using the reader device, acquire the glucoselevel information from the on-body patch device to confirm the presenceof such conditions so that timely corrective actions may be taken.

In certain embodiments, the on-body patch device may include a speakeror an audible output component instead of or in addition to the LEDindicator to provide an audible indication of one or more suchconditions described above. The type of audible output may be programmedor programmable in the on-body patch device, for example, via the readerdevice, and may include a standard audible tone (monotone or multitone), or include one or more ring tones provided to the on-body patchdevice. In certain embodiments, different conditions may be associatedwith a different type of audible output/alert such that the patient orthe user may easily recognize the underlying detected condition based onthe type of audible notification. For example, different levels ofaudible tones may be associated (programmed by the user or the patient,or pre-programmed in the on-body patch device) with different conditionssuch that when asserted, each outputted tone may be easily recognized bythe user or the patient as an indication of the particular associatedcondition. That is, the detected onset of hyperglycemic condition basedon the signal from the analyte sensor may be associated with a firstpredetermined loudness and/or tone, while the detected onset ofhypoglycemic condition based on the signal from the analyte sensor maybe associated with a second predetermined loudness and/or tone.Alternatively, the programmed or programmable audible alerts may includeone or more sequence of audible outputs that are output based on atemporally spaced sequence or a sequence indicating an increase ordecrease in the level of loudness (using the same tone, or graduallyincreasing/decreasing tones).

Furthermore, in aspects of the present disclosure the audible outputindication may be asserted in conjunction with the visual outputindicator, simultaneously or alternatingly, as may be customized orprogrammable in the on-body patch device or pre-programmed.

Referring again to FIG. 6, the antenna 630 and the communication module640 operatively coupled to the control unit 610 may be configured todetect and process the RF power when in predetermined proximity to thereader device/receiver unit providing the RF power, and further, inresponse, to transmit the analyte level information and optionallyanalyte trend information based on stored analyte level data, to thereader device. In certain aspects, the trend information may includes aplurality of analyte level information over a predetermined time periodthat are stored in the memory 620 of the on-body patch device andprovided to the reader device/receiver unit with the real time analytelevel information. For example, the trend information may include aseries of time spaced analyte level data for the time period since thelast transmission of the analyte level information to the reader device.Alternatively, the trend information may include analyte level data forthe prior 30 minutes or one hour that are stored in memory 620 andretrieved under the control of the control unit 610 for transmission tothe reader device.

Referring back to the Figures, in one aspect the on-body patch deviceand the reader device/receiver unit may be configured to communicateusing RFID (radio frequency identification) techniques where the readerdevice/receiver unit is configured to interrogate the on-body patchdevice (associated with an RFID tag) over an RF communication link, suchthat the on-body patch device, in response to the RF interrogationsignal from the reader device, transmits an RF response signalincluding, for example, data associated with the sampled analyte levelfrom the sensor. Additional information regarding the operation of RFIDcommunication can be found in U.S. Patent Publication No. 2009/0108992and U.S. Pat. No. 7,545,272, the disclosure of which are incorporatedherein by reference.

For example, in one embodiment, the reader device/receiver unit mayinclude a backscatter RFID reader configured to transmit an RF fieldsuch that when the on-body patch device is within the transmitted RFfield, its antenna is tuned and in turn provides a reflected or responsesignal (for example, a backscatter signal) to the reader device. Thereflected or response signal may include sampled analyte level data fromthe analyte sensor.

In one aspect, the reader device/receiver unit may be configured suchthat when the reader device/receiver unit is positioned in closeproximity to the on-body patch device and receives the response signalfrom the on-body patch device, the reader device/receiver unit isconfigured to output an indication (audible, visual or otherwise) toconfirm the analyte level measurement acquisition. That is, during thecourse of the 5 to 10 days of wearing the on-body patch device on thebody, the user or the patient may at any time position the readerdevice/receiver unit within a predetermined distance (for example,approximately 1-5 inches) from the on-body patch device, and afterwaiting a few seconds, output an audible indication confirming thereceipt of the real time analyte level information. The received analyteinformation may be output to the display 430 (FIG. 4) of the readerdevice/receiver unit for presentation to the user or the patient.

As shown above, the on-body patch device is configured to be worn over apredetermined time period on the body of the user or the patient.Accordingly, certain embodiments described below include configurationsof the on-body patch device to provide for a compact configuration whichis configured to remain adhered to the skin surface for thepredetermined wear time period comfortably and without detaching fromthe skin surface. For example, in one aspect, the on-body patch devicemay include a single integrated housing or body assembly that includesthe analyte sensor, electronics and an adhesive path. Such configurationprovides for fewer parts that require manipulation by the patient or theuser, leading to improved ease of use, and further, with an overmoldedassembly, may be configured to provide the desired water tight sealduring the course of the wear, preventing moisture or other contaminantsfrom entering into the on-body patch device housing. Such single bodyconfigurations may additionally provide ease of manufacturing with thefewer components that require assembly.

In a further aspect, the on-body patch device may include a two partassembly including a reusable electronics component mated or coupled(detachably or fixedly) to a disposable component including the analytesensor, a base or mount for the electronics component, and the adhesivepatch.

FIG. 7 is a schematic of the reader device/receiver unit for use in theanalyte monitoring systems of FIGS. 1 and 2 in accordance with oneaspect of the present disclosure. Referring to the Figure, the readerdevice/receiver unit 220 (FIG. 2) or the handheld controller inaccordance with one aspect of the present disclosure, includes a surfaceacoustic wave (SAW) resonator 701 which may includes a resonator thatgenerates the RF signal operating in conjunction with an oscillator(OSC) 702. The oscillator 702 is the active RF transistor component, andin conjunction with the SAW resonator 701, is configured to send outcontrol commands (the ping signals), transmit the RF power to receivethe backscatter signal from the on-body patch unit, and generate localoscillation signal to the mixer 703, as described in further detailbelow.

More specifically, in one aspect of the present disclosure, inoperation, the transmit data (TX data) as shown is the control signalreceived from the control unit 410 of the reader device/receiver unit(see e.g., FIG. 4) and received from the power amplifier (PA) 706 is theRF control command to be transmitted to the on-body patch device. TheSAW resonator 701 in one embodiment is configured to provide the carriersignal for the control commands (ping signals). The control signal fromthe control unit 410 in one embodiment include data packets that are tobe transmitted to the on-body patch device to ping it to return aresponse signal back to the reader device.

In one embodiment, before the control signal is sent, a turn on signalfrom the control unit 410 is received at the TX enable line (as shown inFIG. 7) and provided to the oscillator 702. After the control signalfrom the control unit 410 is provided to the oscillator 702 and the SAWresonator 701, the carrier signal which is used to carry the controlsignal is maintained. The same carrier signal in one embodiment may beused to receive the response data packet from the on-body patch device.When the RF control signal is provided to the on-body patch device usingthe loop antenna and over the carrier signal, the RF power is providedat the same time (radiation energy) where the RF power is generated bythe oscillator 702 in conjunction with the SAW resonator 701. In certainaspects, because the carrier signal is maintained duringtransmit/receive time periods between the reader device/receiver unitand the on-body patch device, the RF power is provided during the ping(or control signal) request transmission of the RF control signal andalso during the time period when the backscatter response is receivedfrom the on-body patch device. In certain aspects, the readerdevice/receiver unit loop antenna 708 uses the same carrier signal totransmit the RF power and the RF control signal to the on-body patchdevice.

Referring back to FIG. 7, further shown is an LC power splitter 704which his configured in one aspect of the present disclosure, to splitthe power two ways to the buffer 705 and to the power amplifier (PA)706. The buffer 705 in one embodiment is configured to boost the RFsignal received from LC power splitter 704. Output of the poweramplifier 706 is the control command that is provided to a second LCpower splitter 707 which splits the antenna signal (from the loopantenna into transmit signal (the control signal) and the receive signal(backscatter signal from the on-body patch device)). That is, in oneembodiment, the second LC power splitter 707 may be configured to managethe transmit/receive signals using one loop antenna 708. Referring againto FIG. 7, a balun 709 provided between the loop antenna 708 and thesecond LC power splitter 707 is used in one embodiment to match thebalanced signal from the loop antenna 708 to the unbalanced signal fromthe power splitter 707 (as most circuit components are unbalancedrelative to ground terminal). The balun 709 includes, in one embodiment,an electrical transformer that can convert electrical signals that arebalanced about ground (differential) to signals that are unbalanced(single-ended), and vice versa, using electromagnetic coupling foroperation.

Referring still to FIG. 7, the loop antenna 708 transmits the RF controlsignal (the ping signal) and in response, receives a backscatter signalfrom the on-body patch device. In one aspect, the received backscatterresponse signal by the loop antenna is passed through the balun 709, andto the power splitter 707 to the SAW filter 711. SAW filter 711 in oneaspect includes a bandpass filter configured to remove noise orinterference components in the received backscatter signal, for example.The output of the SAW filter 711 is passed through ASK receiver 720. Inone aspect, the ASK receiver 720 includes a low noise amplifier (LNA)721 whose output is sent to mixer 703 which mixes the low noiseamplified signal output from the LNA 721 with the RF carrier signal fromthe buffer 705.

The output of the mixer 703 is passed to the high pass filter (HPF) 712that filters out the DC component and low frequency components of thesignal, and then the output of the HPF 712 is sent to the intermediatefrequency amplifier (IF amplifier) 713 which is configured to amplifythe received signal. The amplified output signal from the IF amplifier713 is provided to the low pass filter (LPF) 722 of the ASK receiver720, and the output low pass filtered signal from LPF 722 is provided toanother intermediate frequency amplifier 723 of the ASK receiver 720which is configured to amplify the low pass filtered signal output fromthe LPF 722. As shown in FIG. 7, the IF amplifier 723 of the ASKreceiver 720 is provided between the LPF 722 and the ASK demodulator724.

Referring yet still to FIG. 7, the gain controller signal from IFamplifier 723 of the ASK receiver 720 controls the low noise amplifier(LNA) 721 that receives the filtered backscatter signal. The gaincontroller signal in one embodiment switches between high gain and lowgain state of the LNA 721. For example, if IF amplifier 723 has highgain, then the gain controller signal to the LNA 721 switches the LNA721 to low gain operation, and vice versa. As discussed above, theoutput of the IF amplifier 723 of the ASK receiver 720 is provided tothe ASK demodulator 724 of the ASK receiver 720 which is configured todemodulate (or recover the data) the output signal from the IF amplifier723.

That is, as shown in FIG. 7, the RX enable line to the ASK receiver 720is configured to turn on after the TX enable line where the turn onsignal from the control unit 410 (FIG. 4) is received in the readerdevice/receiver unit such that with the receive enable signal from thecontrol unit 410, the data out line (i.e., the output of the ASKdemodulator 724) of the ASK receiver 720 provides the data or signalassociated with the monitored glucose level based on the raw currentsignals from the glucose sensor.

Referring back to the Figures and as described above, in one aspect, theon-body patch device may include a power supply to power the electroniccomponents as well as the sensor, or alternatively, the on-body patchdevice may not includes a separate dedicated power supply and rather,include a self-powered sensor as described in further detail in U.S.patent application Ser. No. 12/393,921 filed Feb. 27, 2009 andincorporated by reference herein for all purposes. In certain aspects,for configurations of the on-body patch device that includes a powersupply, the on-body patch device may be configured to listen for the RFcontrol command (ping signal) from the reader device. More specifically,an On/Off Key (OOK) detector may be provided in the on-body patch devicewhich is turned on and powered by the battery to listen for the RFcontrol command or the ping signal from the reader device. Additionaldetails if the OOK detector are provided in U.S. Patent Publication No.2008/0278333, the disclosure of which is incorporated by reference forall purposes. In certain aspects, when the RF control command isdetected, on-body patch device determines what response packet isnecessary, and generates the response packet for transmission back tothe reader device. In this embodiment, the sensor is always turned onand configured to continuously receive power from the power supply orthe battery of the on-body patch device. However, the sampled currentsignal from the sensor may not be transmitted out to the readerdevice/receiver unit until the on-body patch device receives the RFpower (from the reader device/receiver unit) to enable the transmissionof the data to the reader device. In one embodiment, the battery may bea rechargeable battery configured to be charged when the on-body patchdevice received the RF power (from the reader device/receiver unit).

In certain embodiments, the on-body patch device does not include an RFcommunication chip, nor any other dedicated communication chip to allowfor wireless transmission separate from being powered on based on the RFpower received from the reader device/receiver unit and transmitting thebackscatter response packet to the reader device.

Referring again to FIG. 7, in a further embodiment of the presentdisclosure, an RF transmitter chip or an ASK transmitter may be providedto the reader device/receiver unit 220 (FIG. 2) to replace the SAWresonator 701, the oscillator 702, the mixer 703, the LC power splitter704, the buffer 705, the power amplifier 706, the high pass filter (HPF)712, and the IF amplifier 713 shown in FIG. 7. More specifically, inthis embodiment of the reader device, the RF transmitter chip may becoupled to a crystal which provides the frequency reference base forgenerating the RF carrier signal to receive the backscatter from theon-body patch device, and also to send the control commands (pingsignals) to the on-body patch device.

In the embodiment discussed above, in aspects of the present disclosure,the RF transmitter chip or unit may be coupled to the LC power splitter,a balun and the loop antenna similar to the LC power splitter 707, thebalun 709, and the loop antenna 708 shown in FIG. 7, in addition to aSAW filter and ASK receiver similar to the SAW filter 711 and ASKreceiver 720 shown in FIG. 7. However, in contrast to the configurationshown in FIG. 7, in the alternate embodiment, another crystal may becoupled to the ASK receiver to provide the frequency reference base forreceiving the backscatter signal from the on-body patch device.

FIGS. 8A and 8B illustrate a top view and a side view, respectively, ofantenna and electronic circuit layout of the on-body patch deviceincluding an sensor and sensor electronics assembly for use in theanalyte monitoring systems of FIGS. 1 and 2 in one aspect of the presentdisclosure. Referring to FIGS. 8A and 8B, the loop antenna and circuitlayout of the on-body patch device in one embodiment includes aconductive layer 801, such as a PCB copper trace, provided on asubstrate 802, and further includes, a plurality of inductors 803 a-803e disposed on the substrate and electrically connected to the conductivelayer 801 in a loop configuration. In one aspect, the inductors 803a-803 e are spaced equidistantly from each other around the loopconfiguration. In a further aspect, the inductors 803 a-803 e may not beequidistantly spaced apart from each other in the loop configuration.Also shown in FIGS. 8A and 8B is a data processor or controller 804 inelectrical communication with the conductive layer 801 for processingsignals from the sensor (not shown) and interfacing with the sensor inaddition to processing the control commands from the readerdevice/receiver unit and generating and/or transmitting the backscatterresponse data packet to the reader device.

Accordingly, in aspects of the present disclosure, loop antennaconfigurations are provided for a passive glucose sensor and a low powerglucose reader device/receiver unit at Ultra High Frequency (UHF)frequency bands, providing an on-demand glucose data acquisition systemthat includes the reader device/receiver unit which is configured togenerate a strong near electromagnetic field to power the passiveglucose sensor, and further provide a weak far electromagnetic fieldsuch that the strength of the generated magnetic field at a fardistance, such as approximately 3 meters away from the on-body patchdevice, including the sensor is in compliance with the regulatedradiation level.

In certain embodiments, the on-body patch device antenna may be printedas an internal conductive layer of a printed circuit board surrounded bythe ground plane on the top and bottom layers. That is, in one aspect,the top and bottom conductive layers may be separated by layers ofdielectrics and a conductive layer of loop antenna disposedtherebetween. Further, the antenna for the on-body patch device may beprinted on the top conductive layer of the printed circuit in serieswith a plurality of inductors chips, such as, for example, but notlimited to, five inductor elements.

FIG. 9 illustrates an exemplary circuit schematic of the on-body patchdevice including an sensor and sensor electronics assembly in accordancewith aspects of the present disclosure. Referring to the Figure, in oneembodiment the sensor contacts 910 are provided to establish contactwith the various electrodes of the sensor including working electrode,reference electrode and counter electrode. Also shown is an RFtransmission antenna 920 operatively coupled to the control unit 950. Incertain embodiments, the control unit 950 may be implemented asapplication specific integrated circuits (ASICs), or includemicroprocessors or both. An activation switch 930, described in furtherdetail below, is also shown in FIG. 9 along the electrical path from thepower supply 940 for switching on or turning on the sensor electronicsof the on-body patch device.

Referring still to FIG. 9, also shown in analog front endcircuitry/components 970 coupled to the sensor contacts 910 forprocessing the raw current signals generated by the analyte sensor anddetected at the sensor contacts 910. Additional passive storagecapacitors 960 coupled to the power supply such as a battery is shown.In addition, crystal oscillators 980, 990 are provided as shown in FIG.9, where in certain embodiments, crystal oscillator 980 is configured toprovide clock signals for the state machine in the ASIC 950, whilecrystal oscillator 990 may be configured to provide frequency referencefor the RF communication components within the ASIC 950.

FIG. 10A is a perspective view of the components of the an on-body patchdevice including sensor and sensor electronics assembly in accordancewith one aspect of the present disclosure. Referring to FIG. 10A, anintegrated sensor and sensor electronics assembly/on-body patch device110 of FIG. 1 in one embodiment is shown. As can be seen, the housing1010 in one embodiment is substantially shaped such that the heightprofile is minimized (for example, to less than or equal toapproximately 10 mm, e.g., about 4 mm or less). For example, as shown inthe figures, the housing of the integrated assembly may have a dome-likeshape, or otherwise tapered shape. A height dimension may be at mostabout 4 mm, and may taper (gradually or step wise) to heights less thanabout 4 mm, e.g., 3 mm or less, e.g., 2 mm or less, e.g., 1 mm or less.

Referring back to FIG. 10A, in one embodiment, the analyte sensor 1020is assembled (e.g., provided to the user) with the sensor electronics1030 and provided within the housing 1010. Furthermore an adhesive(single sided or two sided) layer 1040 (FIG. 10C) may be provided on alower surface of the housing 1010 to provide secure positioning of thehousing 1010 on the skin surface during and after sensor deployment. Asdiscussed in further detail below, the integrated sensor and sensorelectronics assembly/on-body patch device 110 may be positioned (e.g.,during manufacture to provide to the user) within the housing of aninsertion device, avoiding the need for a user to align, position, orotherwise connect or couple the sensor and sensor electronics to theinsertion device prior to the insertion of the sensor and turning on thesensor electronics. Accordingly, potential misuse, misalignment of thesensor relative to the introducer of the insertion device, or errors anddifficulties in use of the integrated assembly by the user may beavoided.

FIG. 10B is another perspective view of the components of the on-bodypatch device including sensor and sensor electronics assembly inaccordance with one aspect of the present disclosure. As shown in theFigure, each component of the integrated assembly is separated toillustrate the relative position of each component, in one embodiment.As discussed in further detail below, it can be seen in one embodimentthat the sensor 1020 includes a bent configuration, whereby at least aportion of the body of the sensor is maintained in a directionsubstantially planar to the surface of the skin. In one aspect, thisconfiguration allows for the low profile dimension of the housing 1010that includes the sensor 1020 such that the protrusion of the housing1010, when positioned on the skin surface of the user, is minimized.Accordingly, the sensor 1020 may be bent, or may be bendable, from about1 degree to about 90 degrees or more.

FIG. 10C is another perspective view of the assembled on-body patchdevice including sensor and sensor electronics assembly in accordancewith one aspect of the present disclosure. As shown in FIG. 10C, afterpositioning the integrated sensor and sensor electronics assembly, theadhesive layer 1040 may be configured to substantially fixedly retainthe integrated assembly 110 on the skin surface such that movement ofthe sensor 1020 during the course of wearing the device is minimized. Inone aspect, the adhesive layer 1040 may be configured to provide asubstantially water tight seal between the integrated assembly 110 andthe skin surface during the predetermined time period of wear such thatthe likelihood of the integrated assembly 110 detaching from the skinsurface is minimized.

FIGS. 11A-11C illustrate circuit layouts for the sensor electronicsassembly in the on-body patch device including sensor and sensorelectronics assembly in accordance with embodiments of the presentdisclosure. Referring to FIGS. 11A-11C, embodiments of the sensorelectronics of the integrated assembly includes dimensions that areoptimized for reduction and thus maximized for comfort in use and wear.For example, embodiments of the sensor electronics shown in FIGS.11A-11C may include a diameter of approximately 25 mm or less (typicalsize of a quarter coin, for example), e.g., 20 mm or less, or 15 mm orless. As shown, for example, the control unit including an applicationspecific integrated circuit (ASIC) 1110 is provided in electricalcontact with a plurality of RF communication transmission capacitors1130 positioned, for example, substantially around the outer peripheryof the flexible circuit board. Depending upon the size of the circuitboard and/or RF transmission requirement, RF transmission capacitors1130 of different capacitance may be provided. For example, FIG. 11Aillustrates RF transmission capacitors 1130 of 600 μF, while the FIGS.11B and 11C illustrate RF transmission capacitors 1130 havingapproximately 610 μF and 240 μF, respectively.

Referring back to the Figures, also shown is a battery 1120 configuredto provide the necessary power for the operation of the sensorelectronics, and may include a single use coin-cell type battery that isdisposable after single use, but which is sufficient to provide thenecessary power to operate the integrated sensor and sensor electronicsassembly 110 (FIG. 1) during the desired time period (for example, suchas 5 days or 7 days or longer). Additionally, further shown in FIGS.11A-11C are RF antennas 1140 that are positioned, in one embodimentsubstantially around the circumference of a portion of the flexiblecircuit board.

Accordingly, in aspects of the present disclosure, the circuit layout ofthe sensor electronics may be optimized to minimize the surface area ofthe circuit board (and thus the overall size of the integratedassembly), by positioning the various components in the manner as shownin FIGS. 11A-11C.

FIGS. 12A-12B illustrate pre-deployment and post insertionconfigurations of the insertion device for positioning the on-body patchdevice including sensor and sensor electronics assembly in accordancewith embodiments of the present disclosure. Referring to FIG. 12A,insertion device 1200 in one embodiment includes a housing or body 1210and a cap 1220 which is configured to provide closure or seal on theopen end of the insertion device. As shown, the insertion device 1200may be configured for sensor insertion and sensor electronics assemblypositioning in a direction substantially perpendicular to the skinsurface.

Referring to FIG. 12B, when a force, e.g., a manual force, is appliedupon the top end of the housing 1210 in the direction as shown by arrow1240, and with the open end of the housing on the skin surface 1230, theintegrated sensor and sensor electronics assembly provided within thehousing (not shown) is configured to come into contact with the skinsurface 1230. Furthermore, the force applied as discussed above also maybe configured to move the introducer (not shown) within the housing inthe same direction as shown by arrow 1240 to pierce the skin surface1230 and position the sensor in fluid contact with an analyte of theuser.

Further details of the mechanism associated with the insertion devicefor sensor insertion and sensor electronics assembly positioning isshown and described below in conjunction with FIGS. 12C-12G whichillustrate cross sectional perspective views of the operation of theinsertion device for deploying the on-body integrated sensor and sensorelectronics assembly in accordance with embodiments of the presentdisclosure.

As shown in these figures, in response to the force applied on theinsertion device housing 1210, the introducer 1260 is driven in adirection substantially perpendicular to the skin surface 1230, andalong with the movement of the introducer 1260, the sensor 1280 and thesensor electronics assembly 1270 are moved in the same direction. Whenthe bottom surface of the sensor electronics assembly 1270 comes intocontact with the skin surface 1230, the bottom surface is maintained inan adhered relationship with the skin surface 1230 by, for example, theadhesive layer 1290 (FIG. 12G). Moreover, also shown in the Figures is abias spring 1250 which, in one embodiment, is configured to retract theintroducer needle from the insertion position to a retracted positionwhich is an opposite direction from the direction indicated by arrow1240 (FIG. 12B).

Referring back to the Figure, it can be seen that the introducer needle1260 is substantially and entirely retained within the insertion devicehousing 1210 after sensor insertion, and thereafter, when the insertiondevice 1200 is removed from the skin surface 1230, the sensorelectronics assembly 1270 is retained on the skin surface 1230, whilethe position of the sensor 1280 is maintained in fluid contact with theanalyte of the user under the skin layer 1230.

Prior to activation of the integrated sensor and sensor electronicsassembly for use, there may be a period of time from the manufacturingthat the assembly may be in sleep or idle mode. With a power supply suchas a battery integrated within the assembly, for reasons including costoptimization and prolonging shelf life, embodiments of the presentdisclosure include systems that are activated merely by positioning thesensor and electronics unit on a skin surface as described above, i.e.,no additional action need be required of the user other than applying aforce to housing 1210. As such, insertion of the sensor causesactivation of the electronics unit. In certain embodiments, activationswitch configurations are included which may be configured to betriggered, for example, by the insertion device activation, therebyturning on the integrated sensor and sensor electronics assembly into anactive mode.

For example, FIGS. 13A-13B illustrate embodiments of a power supplyswitch mechanism including conductive plugs of the on-body patch deviceincluding sensor and sensor electronics assembly in accordance withembodiments of the present disclosure. As shown, the sensor electronicsassembly circuit board 1310 may be provided with a physical gap 1350that breaks the electrical circuit between the power supply (e.g.,battery) and the other circuitry of the sensor electronics assembly.

In one embodiment, when the predetermined force is applied on theinsertion device as discussed above, a conductive portion 1320 providedwithin the housing of the sensor electronics may be moved in a directionas shown by arrow 1330 such that electrical contact is established inthe physical gap 1350 on the circuit board, by for example, theconductive portion 1320 coming into physical contact with the conductiveportions 1360 of the circuit board. In this manner, in one embodiment,the electrical path from the power supply and the remaining circuitry onthe circuit board of the sensor electronics is completed, therebypowering the sensor electronics.

By way of another example, referring to FIG. 13B, the conductiveportions 1360 of the circuit board are provided on the board itself, andthe conductive plug 1340, for example, when pushed into the cavity 1350,establishes electrical contact between the conductive portions 1360 ofthe circuit board.

In one embodiment, as discussed above, the actuation of the insertiondevice to position the sensor and sensor electronics assembly triggersthe switch mechanism shown in FIGS. 13A and 13B by also moving theconductive portion 1320 or the conductive plug 1360 in the directioncomplimentary to the direction of the introducer movement, and therebyswitching on the sensor electronics. Within the scope of the presentdisclosure, the activation of the sensor electronics by moving theconductive portion 1320 or the conductive plug may include a separateprocedure, where after positioning the sensor and the sensor electronicsassembly on the skin surface, a predetermined force is applied on thehousing of the integrated sensor and sensor electronics assembly suchthat the desired movement of the conductive portion 1320 or theconductive plug 1360 may be achieved.

FIGS. 13C-13E illustrate another configuration of the power supplyswitch mechanism including conductive pads of the on-body patch deviceincluding sensor and sensor electronics assembly in accordance withembodiments of the present disclosure. Referring to FIG. 13C, an exposedconductive ring 1371 may be provided and configured to contact thesurface of the circuit board in the sensor electronics such that, theinsertion device activation positions the conductive ring 1371 on thesurface of the circuit board so as to complete the electrical contact ofthe sensor electronics assembly (by for example, manual force applied onthe insertion device placing the conductive ring in contact with thecircuit board of the sensor electronics).

Referring to FIG. 13D, in another aspect, electrical contact pads 1372,1373 may be provided to the circuit board in the sensor electronicsassembly such that the mating of the contact pads with the conductivering 1371 switches on the sensor electronics device to provide power tothe device from its power source. FIG. 13E shows yet anotherconfiguration of the switch activation mechanism in accordance with thepresent disclosure, where a portion of the conductive ring 1374 isselectively positioned and provided to establish electrical contact inthe device.

As discussed, each of the activation configuration described aboveincludes a break in the circuitry from the power source such that thepower supply is not drained when the device is not in use, and uponactivation, the break in the electrical contact is completed, therebypowering the device and activating it for operation.

FIG. 14 illustrates a power supply switch mechanism including aninternal switch with a push rod activation of the on-body patch deviceincluding sensor and sensor electronics assembly in accordance withembodiments of the present disclosure. As shown, in one embodiment, pushrod 1410 may be provided and positioned in the sensor electronics suchthat when a force is applied in the direction as shown by arrow 1430,the push rod 1410 is displaced in the same direction, and completes theelectrical contact between the two contacts 1420, 1421. In one aspect,the push rod 1410 may be provided within a seal 1440 such as an O-ringor similar components.

FIG. 15 illustrates a power supply switch mechanism including introducerretraction trigger activation of the on-body integrated sensor andsensor electronics assembly in accordance with embodiments of thepresent disclosure. As shown, a nonconducting needle or device 1510 isprovided to physically separate two electrical contacts 1520, 1521. Eachof the electrical contacts 1520, 1521 is biased or spring loaded to beurged towards each other, physically separated by the nonconductingneedle 1510. Accordingly, when the nonconducting needle 1510 isretracted or pulled away from the sensor electronics assembly in thedirection as shown by arrow 1530, the two electrical contacts 1520, 1521are configured to contact each other, thereby completing the break inthe circuit and establishing electrical connection to activate thesensor electronics assembly.

In one aspect, the nonconducting device or needle 1510 may include, forexample, but not limited to, glass, plastic or any other materialsuitable to separate two electrical contacts and provide insulationtherebetween.

FIG. 16 illustrates a power supply switch mechanism with a contactswitch of the on-body patch device including sensor and sensorelectronics assembly in accordance with embodiments of the presentdisclosure. As shown, in a further aspect, there is provided anelectronic switch 1601 (that is configured to draw an insubstantialamount of power from the sensor electronics power supply), and whentriggered, completes the break between the contacts 1610, 1611 byphysically contacting the two contacts 1610, 1611 with the activationcomponent 1602 that completes the circuit in the sensor electronics fromits power supply such as battery to activate the device for operation.

FIGS. 17A-17B illustrate a power supply switch mechanism with a batterycontact locking mechanism of the on-body patch device including sensorand sensor electronics assembly in accordance with embodiments of thepresent disclosure. Referring to the Figures, in still another aspect,the battery contact of the sensor electronics may be provided with abarbed tab 1710. In post manufacturing shelf mode when the device isnonoperational, the tab 1710 is positioned within the sensor electronicshousing in the position as shown in FIG. 17A so that it is not incontact with the conductive contact 1720 of the sensor electronicscircuit board. When in use as shown in FIG. 17B, the tab 1710 may bebiased such that it physically contacts the conductive contact 1720 onthe circuit board, thereby closing the circuit to/from the battery/powersource and thus activating or switching on the sensor electronics. Asshown in the Figures, the tab 1710 may be configured that upon biasingto establish contact with the conductive contact 1720, it locks orlatches with the conductive contact 1620 and the circuit board so as tomaintain the electrical connection.

FIGS. 18A-18B illustrate a power supply switch mechanism with a bi-modaldome switch of the on-body patch device including sensor and sensorelectronics assembly in accordance with embodiments of the presentdisclosure. Yet in another embodiment, a bi-modal dome shaped switch1810 is provided on the circuit board of the sensor electronics assemblysuch that, when pressed down (as shown in FIG. 18B), the dome shapedlayer 1810 (which may include, for example, a thin sheet metal dome) maybe configured to retain the concave shape as shown in FIG. 18B andeffectively closing the circuit on the circuit board at the contactpoint 1820. In one aspect, the dome shaped layer 1810 may be configuredto shunt to short two or more electrical contacts at the contact point1820 of the circuit board. Alternatively, the dome shaped layer 1810 maybe connected to the circuit board such that one end of the dome shapedlayer 1810 is in contact with one of the two or more open electricalcontacts, and the depression of the dome shaped layer 1810 closes thecircuit on the circuit board by physically contacting the other one ormore of the open electrical contacts.

In the manner described above, in accordance with various embodiments ofthe present disclosure, sensor electronics activation switchconfigurations are provided that may be triggered or activatedautomatically or semi-automatically in response to the activation of theinsertion device described above, or alternatively, may be separatelyactivated by the user by, for example, depressing upon a portion of thehousing or switch provided on the housing of the sensor electronics.Accordingly, power consumption may be optimized for the sensorelectronics assembly while improving post manufacturing shelf life ofthe device prior to use or activation.

As described above, in certain aspects of the present disclosure,discrete glucose measurement data may be acquired on-demand or uponrequest from the reader device, where the glucose measurement isobtained from an in vivo glucose sensor transcutaneously positionedunder the skin layer of a patient or a subject, and further having aportion of the sensor maintained in fluid contact with the interstitialfluid under the skin layer. Accordingly, in aspects of the presentdisclosure, the patient or the user of the analyte monitoring system mayconveniently determine real time glucose information at any time, usingthe RFID communication protocol as described above.

In the manner described above, in accordance with various embodiments ofthe present disclosure, discrete glucose measurements may be obtainedwithin the need for lancing or performing fingerprick test for access toblood sample each time a measurement is desired. The analyte monitoringsystem described in further aspects may be configured to log or storeglucose data monitored by the analyte sensor continuously over apredetermined or programmable time period, or over the life of thesensor without user intervention, and which data may be retrieved at alater time as desired. Furthermore, output indications such as audible,visual or vibratory alerts may be provided to inform the user of apredetermined condition or when the monitored glucose level deviatesfrom a predefined acceptable range (for example, as warning indicationof low glucose or high glucose level).

The various processes described above including the processes operatingin the software application execution environment in the analytemonitoring system including the on-body patch device, sensorelectronics, the reader device, the receiver unit, data processingmodule and/or the remote terminal performing one or more routinesdescribed above may be embodied as computer programs developed using anobject oriented language that allows the modeling of complex systemswith modular objects to create abstractions that are representative ofreal world, physical objects and their interrelationships. The softwarerequired to carry out the inventive process, which may be stored in amemory or storage device of the storage unit of the various componentsof the analyte monitoring system described above in conjunction to theFigures including the on-body patch device, the reader device, the dataprocessing module, various described communication devices, or theremote terminal may be developed by a person of ordinary skill in theart and may include one or more computer program products.

In still another aspect, the methods, devices and systems describedabove may be configured to log and store (for example, with anappropriate time stamp and other relevant information such as, forexample, contemporaneous temperature reading)) the real time analytedata received from the analyte sensor, and may be configured to providethe real time analyte data on-demand by using, for example a device suchas a blood glucose meter or a controller discussed above that isconfigured for communication with the on-body integrated sensor andsensor electronics assembly.

That is, in one embodiment, real time data associated with the analytebeing monitored is continuously or intermittently measured and stored inthe integrated on-body sensor and sensor electronics assembly, and uponrequest from another device such as the receiver unit or the readerdevice/receiver unit (operated by the user, for example) or any othercommunication enabled device such as a cellular telephone, a personaldigital assistant, an iPhone, a Blackberry device, a Palm device such asPalm Treo, Pro, Pre, Centro), or any other suitable communicationenabled device which may be used to receive the desired analyte datafrom the on-body integrated sensor and sensor electronics assembly whilebeing worn and used by the user. In one aspect, such communicationenabled device may be positioned within a predetermined proximity to theintegrated on-body sensor and sensor electronics assembly, and when thecommunication enabled device is positioned within the predeterminedproximity, the data from the integrated on-body sensor and sensorelectronics assembly may be transmitted to the communication enableddevice. In one aspect, such data communication may include inductivecoupling using, for example, electromagnetic fields, Zigbee protocolbased communication, or any other suitable proximity based communicationtechniques. In this manner, glucose on-demand mode may be provided suchthat the information associated with contemporaneously monitored analytelevel information is provided to the user on-demand from the user.

In this manner, in embodiments of the present disclosure, the size anddimension of the on-body sensor electronics may be optimized forreduction by, for example, flexible or rigid potted or low pressure/lowtemperature overmolded circuitry that uses passive and active surfacemount devices for securely positioning and adhering to the skin surfaceof the user. When flexible circuitry is with or in the overmold, thesensor electronics may includes the analyte sensor and/or otherphysiological condition detection sensor on the flex circuit.Furthermore in embodiments of the present disclosure, one or moreprinted RF antenna may be provided within the sensor electronicscircuitry for RF communication with one or more remote devices, andfurther, the device operation and/or functionalities may be programmedor controlled using one or more a microprocessors, or applicationspecific integrated circuits (ASIC) to reduce the number of internalcomponents.

Embodiments of the present disclosure include one or more low pressuremolding materials that directly encapsulate the integrated circuits orthe sensor electronic components. The thermal process entailed in theencapsulation using the low pressure molding materials may be configuredto shield temperature sensitive components such as, for example, theanalyte sensor or other components of the sensor electronics from theheat generated during the thermal overmolding process. Other techniquessuch as injection molding and/or potting may be used.

In another aspect, the sensor electronics may be molded using opticaltechniques such as with a UV cured material, for example, or using twophoton absorption materials, which may also be used to reduce the deador unused volume surrounding the sensor electronics within the housingof the device such that the reduction of its size and dimension may beachieved. Moreover, the sensor electronics may be configured to reducethe number of components used, for example, by the inclusion of anapplication specific integrated circuit (ASIC) that may be configured toperform the one or more functions of discrete components such as apotentiostat, data processing/storage, thermocouple/thermister, RFcommunication data packet generator, and the like. Additionally, a fieldprogrammable gate array (FPGA) or any other suitable devices may be usedin addition to the ASIC in the sensor electronics to reduce the on-bodydevice dimension.

Also, embodiments of the present disclosure includes analyte sensorsthat may be fabricated from flex circuits and integrated with the sensorelectronics within the device housing, as a single integrated device.Example of flex circuits may include evaporated or sputtered gold onpolyester layer, single or multi-layer copper or gold on polymide flexcircuit. When the sensor fabricated from a copper or gold polymide flexcircuit, gold or other inert material may be selectively plated on theimplantable portion of the circuit to minimize the corrosion of thecopper. In aspects of the present disclosure, the flex circuit may bedie or laser cut, or alternatively chemically milled to define thesensor from the flex circuit roll.

A further configuration of embodiments of the present disclosureincludes RF communication module provided on the flex circuit instead ofas a separate component in the sensor electronics. For example, the RFantenna may be provided directly on the flex circuit by, such assurrounding the sensor electronics components within the housing on theflex circuit, or folded over the components, and encapsulated with theelectronic components within the housing of the device.

In accordance with embodiments of the present disclosure, the integratedsensor and sensor electronics assembly may be positioned on the skinsurface of the user using an insertion device. For example, automated orsemi-automated, spring biased and/or manual insertion device may beprovided to deploy the sensor and the sensor electronics such that theimplantable portion of the sensor is positioned in fluid contact withthe analyte of the user such as the interstitial fluid, while thehousing of the sensor electronics is securely positioned and adhered tothe skin surface. In embodiments of the present disclosure, the sensorelectronics device (for example, a transmitter unit of an analytemonitoring system) may be switched to an operational state or condition(from an inactive, shelf mode) upon deployment of the integratedassembly by the insertion device.

In one aspect, integrated sensor and sensor electronics assembly may bepre-loaded or otherwise pre-assembled within the insertion device, suchthat, when in use, the user may, by a single operation of the insertiondevice, deploy the integrated sensor and sensor electronics assembly,without the need to couple the integrated assembly with the insertiondevice prior to deployment.

In one aspect, the integrated sensor and sensor electronics assembly andthe insertion device may be sterilized and packaged as one single deviceand provided to the user. Furthermore, during manufacturing, theinsertion device assembly may be terminal packaged providing costsavings and avoiding the use of, for example, costly thermoformed trayor foil seal. In addition, the inserter device may include an end capthat is rotatably coupled to the insertion device body, and whichprovides a safe and sterile environment (and avoid the use of desiccantsfor the sensor) for the sensor provided within the insertion devicealong with the integrated assembly. Also, the insertion device sealedwith the end cap may be configured to retain the sensor within thehousing from significant movement during shipping such that the sensorposition relative to the integrated assembly and the insertion device ismaintained from manufacturing, assembly and shipping, until the deviceis ready for use by the user.

Moreover, as discussed above, the insertion device in embodiments of thepresent disclosure includes a sharp needle or introducer for aiding thetranscutaneous insertion of the sensor through the skin layer of theuser. The sharp needle or the introducer may be configured to beretracted within the insertion device housing after deployment to permitmovement, such as tilting or angled movement, to position the adhesiveon the housing of the sensor electronics onto the skin surface of theuser without the introducer interfering such movement. Also, byretaining the introducer within the insertion device housing afterinsertion, the disposal of the used introducer may be safer, withoutpresenting possible biohazard concerns.

Also, in embodiments of the present disclosure the sharp needle or theintroducer is not visible to the user prior to, during and after the useof the insertion device to position the sensor and the sensorelectronics. As such, potential for perceived pain associated with whenthe sharp needle is visible is minimized.

In a further embodiment, the insertion device may be configured formanual deployment with spring biased or automatic refraction of theintroducer. That is, sensor insertion, the user may apply apredetermined amount of pressure upon the housing of the insertiondevice to insert the introducer and the sensor, the applied pressuresufficient to pierce through the skin layer of the user, and the devicehousing configured such that the applied pressure or the distancetraveled by the introducer is predetermined (for example, by the use ofa stopper or a protrusion within the inner wall of the insertion devicethat effectively stops of blocks further downward movement of theintroducer towards the skin piercing direction after the introducer hasreached a predetermined distance. In one aspect, the applied pressuremay be configured to also press down upon a spring or a bias mechanismprovided within the housing of the insertion device such that, when theapplied pressure is released, the introducer is automatically retractedto its original pre-deployment position within the housing of theinsertion device, by the return force from the spring or bias mechanism.

In this manner, consistent and repeatable insertion depth for theplacement of the analyte sensor may be achieved. Furthermore, theinsertion device housing (for example, a plastic or a combination ofplastic and metal housing) may not be under the stress of spring tensionsince the bias spring provided for refraction of the introducer is, inthe predeployment state, unbiased and in a relaxed state.

In a further embodiment, two sided adhesive layer may be provided alongthe other periphery of the insertion device that is positioned to be incontact with the skin surface of the user such that, proper alignmentand positioning of the introducer, the sensor and the sensor electronicsassembly may be provided before and during the sensor positioningprocess, in addition to increased comfort and breathability of thematerial once adhered to the skin layer of the user.

In one embodiment, an integrated analyte monitoring device assembly maycomprise an analyte sensor for transcutaneous positioning through a skinlayer and maintained in fluid contact with an interstitial fluid underthe skin layer during a predetermined time period, the analyte sensorhaving a proximal portion and a distal portion, and sensor electronicscoupled to the analyte sensor, the sensor electronics comprising acircuit board having a conductive layer and a sensor antenna disposed onthe conductive layer, one or more electrical contacts provided on thecircuit board and coupled with the proximal portion of the analytesensor to maintain continuous electrical communication, and a dataprocessing component provided on the circuit board and in signalcommunication with the analyte sensor, the data processing componentconfigured to execute one or more routines for processing signalsreceived from the analyte sensor, the data processing componentconfigured to control the transmission of data associated with theprocessed signals received from the analyte sensor to a remote locationusing the sensor antenna in response to a request signal received fromthe remote location.

The proximal portion of the analyte sensor and the circuit board may beencapsulated.

The proximal portion of the analyte sensor and the circuit board may beencapsulated with a potting material.

The circuit board may include an upper layer and a lower layer, wherethe conductive layer is disposed between the upper layer and the lowerlayer.

The antenna may include a loop antenna or a dipole antenna.

The antenna may be printed on the conductive layer.

In one aspect, the assembly may include a plurality of inductivecomponents coupled to the sensor antenna on the conductive layer of thecircuit board.

The plurality of inductive components may be coupled in series to thesensor antenna.

The plurality of inductive components may be positioned substantiallyaround an outer edge of the circuit board.

The circuit board may be substantially circular, and the plurality ofcomponents may be positioned around the outer circumference of thecircular circuit board.

Each of the plurality of the inductive components may be positionedsubstantially equidistant to each other on the circuit board.

Moreover, the assembly may include a power supply to provide power tothe sensor electronics.

The data processing component may include an application specificintegrated circuit (ASIC) disposed on the circuit board and configuredto process signals from the analyte sensor.

The data processing component may include a state machine.

The state machine may be configured to execute one or more programmed orprogrammable logic for processing the signals received from the analytesensor.

The analyte sensor may include a glucose sensor.

In another embodiment, an analyte data acquisition device may comprise acontrol unit configured to generate a control command based on a carriersignal, an antenna section coupled to the control unit to transmit thecontrol command with the carrier signal and to receive a backscatterresponse data packet using the carrier signal, and a receiver sectioncoupled to the antenna section and the control unit to process thereceived backscatter response data packet and to generate an outputglucose data.

The control unit may include a signal resonator coupled to anoscillator, and configured to generate RF power.

The signal resonator may include a surface acoustic wave resonator.

The generated RF power and the control command may be transmitted withthe carrier signal.

The control command may include an RF control command transmitted withthe carrier signal to a remote location.

The backscatter response data packet may be received from the remotelocation when the antenna is positioned no more than approximately teninches from the remote location.

The antenna may be positioned about five inches or less from the remotelocation.

The antenna section may include one or more of a loop antenna, or adipole antenna.

The control unit may be configured to generate the carrier signal.

The receiver section may include a filter to filter the receivedbackscatter response data packet.

A further aspect may include an output unit operatively coupled to thecontrol unit to output an indication corresponding to the generatedglucose data.

The outputted indication may include one or more of a visual output, anaudible output, a vibratory output, or one or more combinations thereof.

The control unit may generate a receipt confirmation signal uponsuccessful receipt of the backscatter response data packet.

The generated receipt confirmation signal may be output to the user.

In another aspect, the device may further include a storage devicecoupled to the control unit to store the generated control command,carrier signal, the received backscatter response data packet, thegenerated output glucose data, or one or more combinations thereof.

The storage device may include a nonvolatile memory device.

The control unit may include a microprocessor.

The control unit may include an application specific integrated circuit.

Yet another aspect may include a strip port for receiving an in vitroblood glucose test strip, the strip port including an electricalconnection in signal communication with the control unit.

The control unit may be configured to process a sample on the test stripto determine a corresponding blood glucose level.

In another embodiment, an integrated analyte monitoring device maycomprise a sensor electronics assembly including an analyte sensor, apower supply, an activation switch operatively coupled to the powersupply and the analyte sensor, a controller unit in electrical contactwith the analyte sensor and the activation switch having one or moreprogramming instructions stored therein for execution, the controllerunit configured to process one or more signals received from the analytesensor when the activation switch is triggered, and an insertion deviceincluding a housing, an introducer coupled to the housing configured tomove between a first position and a second position, and a biasmechanism operatively coupled to the housing configured to automaticallyretract the introducer from the second position to the first position.

The sensor electronics assembly may be retained entirely within thehousing of the insertion device prior to the introducer movement fromthe first position to the second position.

The activation switch may be not triggered until the introducer hasreached the second position.

The analyte sensor may include a glucose sensor.

The activation switch may be triggered after the introducer has reachedthe second position, and prior to the introducer retraction from thesecond position to the first position.

The introducer may engage with the analyte sensor during its movementfrom the first position to the second position, and further, wherein theintroducer disengages from the analyte sensor during its movement fromthe second position to the first position.

The movement of the introducer from the first position to the secondposition may be in response to a manual force applied on the housing.

The bias mechanism may include a spring.

A further aspect may include an adhesive layer provided on a bottomsurface of the housing for placement on a skin layer.

The adhesive layer may be configured to retain the sensor electronicsassembly on the skin layer for a predetermined time period.

The power supply may include a single use disposable battery.

The active operational life of the power supply may exceed the activeoperational life of the analyte sensor.

Moreover, one aspect may include a cap configured to mate with an openend of the housing of the insertion device.

When the cap is coupled to the housing, the interior space of thehousing may be maintained in a substantially contaminant freeenvironment.

The sensor electronics assembly may include a printed circuit boardincluding a portion of the analyte sensor permanently connected thereto.

The controller unit may include an application specific integratedcircuit (ASIC).

The movement of the introducer between the first position and the secondposition may be at an angle at approximately 90 degrees or less from askin surface.

The sensor electronics assembly may include a housing having a height ofless than approximately 4 mm.

Various other modifications and alterations in the structure and methodof operation of this disclosure will be apparent to those skilled in theart without departing from the scope and spirit of the embodiments ofthe present disclosure. Although the present disclosure has beendescribed in connection with particular embodiments, it should beunderstood that the present disclosure as claimed should not be undulylimited to such particular embodiments. It is intended that thefollowing claims define the scope of the present disclosure and thatstructures and methods within the scope of these claims and theirequivalents be covered thereby.

1. An integrated analyte monitoring device assembly, comprising: ananalyte sensor for transcutaneous positioning through a skin layer andmaintained in fluid contact with an interstitial fluid under the skinlayer during a predetermined time period, the analyte sensor having aproximal portion and a distal portion; and sensor electronics coupled tothe analyte sensor, the sensor electronics comprising: a circuit boardhaving a conductive layer and a sensor antenna disposed on theconductive layer; one or more electrical contacts provided on thecircuit board and coupled with the proximal portion of the analytesensor to maintain continuous electrical communication; and a dataprocessing component provided on the circuit board and in signalcommunication with the analyte sensor, the data processing componentconfigured to execute one or more routines for processing signalsreceived from the analyte sensor, the data processing componentconfigured to control the transmission of data associated with theprocessed signals received from the analyte sensor to a remote locationusing the sensor antenna in response to a request signal received fromthe remote location.
 2. The assembly of claim 1 wherein the proximalportion of the analyte sensor and the circuit board are encapsulated. 3.The assembly of claim 2 wherein the proximal portion of the analytesensor and the circuit board are encapsulated with a potting material.4. The assembly of claim 1 wherein the circuit board includes an upperlayer and a lower layer, where the conductive layer is disposed betweenthe upper layer and the lower layer.
 5. The assembly of claim 1 whereinthe antenna includes a loop antenna or a dipole antenna.
 6. The assemblyof claim 1 wherein the antenna is printed on the conductive layer. 7.The assembly of claim 1 further including a plurality of inductivecomponents coupled to the sensor antenna on the conductive layer of thecircuit board.
 8. The assembly of claim 7 wherein the plurality ofinductive components are coupled in series to the sensor antenna.
 9. Theassembly of claim 7 wherein the plurality of inductive components arepositioned substantially around an outer edge of the circuit board. 10.The assembly of claim 9 wherein the circuit board is substantiallycircular, and the plurality of components are positioned around theouter circumference of the circular circuit board.
 11. The assembly ofclaim 7 wherein each of the plurality of the inductive components arepositioned substantially equidistant to each other on the circuit board.12. The assembly of claim 1 including a power supply to provide power tothe sensor electronics.
 13. The assembly of claim 1 wherein the dataprocessing component includes an application specific integrated circuit(ASIC) disposed on the circuit board and configured to process signalsfrom the analyte sensor.
 14. The assembly of claim 1 wherein the dataprocessing component includes a state machine.
 15. The assembly of claim14 wherein the state machine is configured to execute one or moreprogrammed or programmable logic for processing the signals receivedfrom the analyte sensor.
 16. The assembly of claim 1 wherein the analytesensor includes a glucose sensor.
 17. An analyte data acquisitiondevice, comprising: a control unit configured to generate a controlcommand based on a carrier signal; an antenna section coupled to thecontrol unit to transmit the control command with the carrier signal andto receive a backscatter response data packet using the carrier signal;and a receiver section coupled to the antenna section and the controlunit to process the received backscatter response data packet and togenerate an output glucose data.
 18. The device of claim 17 wherein thecontrol unit includes a signal resonator coupled to an oscillator, andconfigured to generate RF power.
 19. The device of claim 18 wherein thesignal resonator includes a surface acoustic wave resonator.
 20. Thedevice of claim 18 wherein the generated RF power and the controlcommand are transmitted with the carrier signal.
 21. The device of claim17 wherein the control command includes an RF control commandtransmitted with the carrier signal to a remote location.
 22. The deviceof claim 21 wherein the backscatter response data packet is receivedfrom the remote location when the antenna is positioned no more thanapproximately ten inches from the remote location.
 23. The device ofclaim 22 wherein the antenna is positioned about five inches or lessfrom the remote location.
 24. The device of claim 17 wherein the antennasection includes one or more of a loop antenna, or a dipole antenna. 25.The device of claim 17 wherein the control unit is configured togenerate the carrier signal.
 26. The device of claim 17 wherein thereceiver section includes a filter to filter the received backscatterresponse data packet.
 27. The device of claim 17 including an outputunit operatively coupled to the control unit to output an indicationcorresponding to the generated glucose data.
 28. The device of claim 27wherein the outputted indication includes one or more of a visualoutput, an audible output, a vibratory output, or one or morecombinations thereof.
 29. The device of claim 17 wherein the controlunit generates a receipt confirmation signal upon successful receipt ofthe backscatter response data packet.
 30. The device of claim 29 whereinthe generated receipt confirmation signal is output to the user.
 31. Thedevice of claim 17 further including a storage device coupled to thecontrol unit to store the generated control command, carrier signal, thereceived backscatter response data packet, the generated output glucosedata, or one or more combinations thereof.
 32. The device of claim 31wherein the storage device includes a nonvolatile memory device.
 33. Thedevice of claim 17 wherein the control unit includes a microprocessor.34. The device of claim 17 wherein the control unit includes anapplication specific integrated circuit.
 35. The device of claim 17further including a strip port for receiving an in vitro blood glucosetest strip, the strip port including an electrical connection in signalcommunication with the control unit.
 36. The device of claim 35 whereinthe control unit is configured to process a sample on the test strip todetermine a corresponding blood glucose level.
 37. An integrated analytemonitoring device, comprising: a sensor electronics assembly including:an analyte sensor; a power supply; an activation switch operativelycoupled to the power supply and the analyte sensor; a controller unit inelectrical contact with the analyte sensor and the activation switchhaving one or more programming instructions stored therein forexecution, the controller unit configured to process one or more signalsreceived from the analyte sensor when the activation switch istriggered; and an insertion device including: a housing; an introducercoupled to the housing configured to move between a first position and asecond position; and a bias mechanism operatively coupled to the housingconfigured to automatically retract the introducer from the secondposition to the first position.
 38. The device of claim 37 wherein thesensor electronics assembly is retained entirely within the housing ofthe insertion device prior to the introducer movement from the firstposition to the second position.
 39. The device of claim 37 wherein theactivation switch is not triggered until the introducer has reached thesecond position.
 40. The device of claim 37 wherein the analyte sensorincludes a glucose sensor.
 41. The device of claim 37 wherein theactivation switch is triggered after the introducer has reached thesecond position, and prior to the introducer refraction from the secondposition to the first position.
 42. The device of claim 37 wherein theintroducer engages with the analyte sensor during its movement from thefirst position to the second position, and further, wherein theintroducer disengages from the analyte sensor during its movement fromthe second position to the first position.
 43. The device of claim 37wherein the movement of the introducer from the first position to thesecond position is in response to a manual force applied on the housing.44. The device of claim 37 wherein the bias mechanism includes a spring.45. The device of claim 37 including an adhesive layer provided on abottom surface of the housing for placement on a skin layer.
 46. Thedevice of claim 45 wherein the adhesive layer is configured to retainthe sensor electronics assembly on the skin layer for a predeterminedtime period.
 47. The device of claim 37 wherein the power supplyincludes a single use disposable battery.
 48. The device of claim 37wherein the active operational life of the power supply exceeds theactive operational life of the analyte sensor.
 49. The device of claim37 including a cap configured to mate with an open end of the housing ofthe insertion device.
 50. The device of claim 49 wherein when the cap iscoupled to the housing, the interior space of the housing is maintainedin a substantially contaminant free environment.
 51. The device of claim37 wherein the sensor electronics assembly includes a printed circuitboard including a portion of the analyte sensor permanently connectedthereto.
 52. The device of claim 37 wherein the controller unit includesan application specific integrated circuit (ASIC).
 53. The device ofclaim 37 wherein the movement of the introducer between the firstposition and the second position is at an angle at approximately 90degrees or less from a skin surface.
 54. The device of claim 37 whereinthe sensor electronics assembly includes a housing having a height ofless than approximately 4 mm.